[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intradialytic-hypotension\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intradialytic-hypotension":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,50,78,106,130,162,190,216,242,269,296,323,352],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100606757","using-a-hypotension-prediction-index-to-prevent-low-blood-pressure-during-dialysis-in-icu-patients-100606757",false,"NCT07179705","Using a Hypotension Prediction Index to Prevent Low Blood Pressure During Dialysis in ICU Patients","Hypotension Prediction Index Guided Prevention of Intradialytic Hypotension During Intermittent Renal Replacement Therapy in Intensive Care Units","HyPIR-ICU","Inclusion Criteria:\n\n* Adults \\>18 years old\n* Diagnosed with acute kidney injury (AKI) or end-stage kidney disease (ESKD)\n* Admitted to medical ICU\n* Scheduled for PIRRT\n* Have an indwelling arterial catheter\n\nExclusion Criteria:\n\n* Severe right heart dysfunction, significant valvular disease, arrhythmias, mechanical circulatory support, absence of arterial access, no UF prescription, palliative care, or expected ICU stay \\\u003C72 hours.","ALL","18 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"NA","This single-center, crossover randomized controlled trial (HyPIR-ICU) investigates whether a Hypotension Prediction Index (HPI)-guided management strategy can reduce intradialytic hypotension (IDH) during prolonged intermittent renal replacement therapy (PIRRT) in critically ill patients. All participants must have an indwelling arterial catheter for continuous hemodynamic monitoring.",[27,28,29],"Intradialytic Hypotension","Intensive Care Unit ICU","Hemodialysis Patients",[31,32,33,34,35,36],"Hypotension Prediction Index (HPI)","Prolonged intermittent renal replacement therapy (PIRRT)","Slow-low efficiency dialysis","Intradialytic hypotension","Hemodynamic monitoring","Intensive Care Unit","RECRUITING","2026-05-05",{"date":40,"type":41},"2026-05-07","ACTUAL",{"date":43,"type":41},"2025-10-10",{"date":45,"type":21},"2026-12-31",{"name":47,"class":48},"Chulalongkorn University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100511228","improved-hemodynamic-tolerance-of-intermittent-hemodialysis-sessions-in-intensive-care-unite-using-citrate--vs-acetate-based-dialysate-100511228","NCT05936710","Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite Using Citrate- vs Acetate-based Dialysate","Improved Hemodynamic Tolerance of Intermittent Hemodialysis Sessions in Intensive Care Unite (ICU) Using Citrate- vs Acetate-based Dialysate","HEMODIACIDE","Inclusion Criteria:\n\n* Patient ≥ 18 years old\n* Patient hospitalized in an intensive care unit\n* Patient with acute renal failure defined by a KDIGO stage ≥ 1 and suspected non-obstructive\n* Patient at risk of per dialytic hypotension (capillary refill time ≥ 3 seconds and\u002For cardiovascular SOFA ≥ 1 and\u002For lactatemia \\> 2mmol\u002FL)\n* Indication for Extra Renal Replacement Therapy with IHD.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Known chronic renal insufficiency of any stage\n* Cardio-renal and hepato renal syndrome\n* Unstable hemodynamic state: refractory shock\n* Patient included in another interventional study likely to modify the hemodynamic state\n* Patient deprived of liberty\n* Patient under guardianship or curatorship\n* Patient not affiliated to a social security system",{"count":59,"type":21},48,[24],"During intermittent hemodialysis (IHD), the occurrence of intradialytic hemodynamic instability (IHI) is frequent in ICU and impacted morbidity and mortality. Bicarbonate dialysate buffer improves hemodynamic tolerance compared to acetate dialysate buffer. However, bicarbonate dialysate buffer still contains a lower concentration of acetate, which could contribute to hemodynamic instability. Recently, citrate-based dialysate in bicarbonate hemodialysis instead of acetate have been proposed. They have the appropriate authorizations for routine use. The aim of this study is to compare acetate- vs citrate-based dialysate in terms of hemodynamic tolerance and effectiveness.",[27],[64,65,66,67],"citrate based dialysate","acetate based dialysate","hypotension","hemodynamic tolerance",{"date":69,"type":41},"2026-05-08",{"date":71,"type":41},"2023-12-07",{"date":73,"type":21},"2027-07",{"name":75,"class":76},"Centre Hospitalier de Bethune","NETWORK",5,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":49},"100503401","phase-3-prevention-of-intradialytic-hypotension-by-inhibiting-bradykinin-b2-receptor-100503401","NCT05834777","Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor","Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor A Randomized, Double-blind, Placebo-controlled, Cross Over Explorative Study","Inclusion Criteria:\n\n* Patients ≥ 18 to ≤ 80 years of age\n* Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for at least 6 months, receiving 3 dialysis sessions per week and who are in a stable clinical condition per investigator's judgement\n* Patients on hemodialysis with at least 6 IDH episodes during the last 8 weeks based on medical record assessment\n* Pre-dialysis systolic blood pressure ≥ 110 and ≤ 170 mmHg assessed by two consecutive and averaged pre-HD blood pressure measurments\n* Patients adequately hemodialyzed with a Kt\u002FV ≥ 1.2\n* Patients whose treatment regimen remained unchanged within 14 days prior to dosing (diet, medication, dry weight, treatment time, dialysate composition and temperature, dialysis shift, blood flow, and dialysate flow, vascular access)\n* Female subjects \\\u003C 55 years of age to agree on effective contraception methods throughout the study period and who have a negative pregnancy test before initiating study activities\n* Body weight ≤ 150 kg\n\nExclusion Criteria:\n\n* Patients who have been hospitalized during the last 4 weeks before enrolment, except vascular access related hospitalization\n* Patients with known clinically evident inflammatory or infectious disease per investigator's evaluation\n* Severe anemia with a hemoglobin (Hb) \\\u003C 8.0 g\u002FdL at screening\n* Platelet count \\\u003C 50 x 109\u002FL\n* Hepatic disease associated with ALT \\> 3x ULN, or total bilirubin \\>2x ULN with direct bilirubin \\> 20% of the total bilirubin level\n* Known bleeding disorders e.g., von-Willebrand disease or Hemophilia A, B, C, etc.\n* Recent (\\\u003C3 months before screening) thromboembolic event, e.g., acute coronary syndrome, stroke, or venous thrombosis embolism (except dialysis access thrombosis)\n* Recent (\\\u003C3 months before screening) major surgery or scheduled major surgery during study participation\n* Scheduled living donor renal transplant during study participation\n* Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher\n* Receiving antiplatelet therapy except daily ASA ≤ 150 mg\u002Fday\n* Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure\n* Patients with significant pre-dialysis overload as defined by \\> 5kg above dry weight estimated by bioimpedance spectroscopy\n* Patient's life expectancy \\\u003C 6 months per investigator's judgement","80 Years",{"count":87,"type":21},26,[89],"PHASE3","Currently, there is no medication available to adequately treat patients undergoing hemodialysis who are suffering from intradialytic hypotension (IDH). Medical interventions such as Trendelenburg positioning, saline bolus administration, reduction of ultrafiltration rate, interruption of the hemodialysis, and other medical treatments are the methods of choice to treat the hypotensive condition of these patients and thus to maintain the systolic blood pressure. Patients suffering from IDH have a higher reported mortality rate due to the given stress on their cardiovascular system. New treatments, therefore, would give clinicians an additional alternative to current existing approaches and might help patients to maintain their blood pressure during hemodialysis.\n\nThe main objective of the study is to evaluate the efficacy of icatibant in the prevention of systolic blood pressure (SBP) drop in patients on hemodialysis suffering from recurrent IDH episodes during hemodialysis.",[27],[93,34,94,95,96],"Hemodialysis","Bradykinin","Kallikrein-Kinin System","Icatibant","2026-04-10",{"date":99,"type":41},"2026-04-15",{"date":101,"type":41},"2023-12-11",{"date":103,"type":21},"2026-11-01",{"name":105,"class":48},"Vanderbilt University Medical Center",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":49},"100625640","phase-2-a-pilot-trial-of-chinese-medicine-for-patients-with-dialytic-hypotension-100625640","NCT07425262","A Pilot Trial of Chinese Medicine for Patients With Dialytic Hypotension","A Pilot Randomized Waitlist-controlled Trial of a Zheng-based Chinese Medicine Intervention for Patients With Dialytic Hypotension in Taiwan","Inclusion Criteria:\n\n* Maintenance bicarbonate hemodialysis (HD) for more than 1 year, three times a week 3.5 to 4.5 h HD schedule.\n* Have experienced more than 30% episodes of IDH (defined as a systolic BP\\\u003C90 mmHg on dialysis or requirement for clinical intervention) during the exposure assessment period (months 1-3) of this study\n* Cognitive ability to give written informed consent.\n\nExclusion Criteria:\n\n* Allergic history to Chinese herbal medicine\n* Systemic diseases such as coagulation disorders, malignancy, liver diseases and cardiovascular diseases.\n* Estimated survival time \\\u003C 1 year.\n* Mental illness.\n* Participate in other clinical trials.",{"count":114,"type":21},100,[116,89],"PHASE2","To evaluate the epidemiological status of traditional Chinese Medicine (TCM) constitution in patients with dialytic hypotension, and design a clinical study based on a Zheng-based herbal formulation to evaluate the clinical efficacy and safety of TCM",[119,27],"End Stage Renal Disease on Dialysis","NOT_YET_RECRUITING","2026-02-23",{"date":123,"type":41},"2026-02-25",{"date":125,"type":21},"2026-02-02",{"date":127,"type":21},"2028-02-01",{"name":129,"class":48},"Chang Gung Memorial Hospital",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":140,"studyType":141,"phases":4,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":4},"100623517","ultrasound-based-prediction-of-hemodynamic-instability-during-cvvhdf-initiation-100623517","NCT07397663","Ultrasound-Based Prediction of Hemodynamic Instability During CVVHDF Initiation","Prediction of Intradialytic Hypotension at the Initiation of Continuous Venovenous Hemodiafiltration Using Multimodal Ultrasonographic and Hemodynamic Parameters in Intensive Care Unit Patients","US-CVVHDF","Inclusion Criteria:\n\n* Adult patients (≥18 years) admitted to the intensive care unit\n* Indication for continuous venovenous hemodiafiltration\n* Adequate transthoracic echocardiographic image quality\n* Written informed consent obtained from legal representatives\n\nExclusion Criteria:\n\n* Acute coronary syndrome\n* Severe valvular heart disease or pericardial effusion\n* Significant arrhythmias interfering with Doppler measurements\n* Presence of pacemaker, ICD, or ventricular assist device\n* Poor echocardiographic imaging window\n* Life expectancy less than 24 hours",{"count":139,"type":21},80,"1 Year","OBSERVATIONAL","This prospective observational study aims to evaluate the ability of transthoracic echocardiographic and bedside ultrasonographic parameters to predict intradialytic hypotension and hemodynamic instability at the initiation of continuous venovenous hemodiafiltration (CVVHDF) in adult intensive care unit patients.",[144,27,145],"Renal Failure , Chronic","Critical Illness",[27,147,148,149,150,151],"LVOT VTI","CVVHD","Renal Resistive Index","Echocardiography","VExUS","2026-02-11",{"date":154,"type":41},"2026-02-13",{"date":156,"type":21},"2026-02-10",{"date":158,"type":21},"2027-02-10",{"name":160,"class":161},"Bursa Yuksek Ihtisas Training and Research Hospital","OTHER_GOV",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":177,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":49},"100375064","blood-pressure-slopes-and-ultrafiltration-in-hemodialysis-patients-100375064","NCT04163614","Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients","Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration in Hemodialysis Patients","Inclusion Criteria:\n\n* Hemodialysis patient\n* Pre-dialysis systolic blood pressure greater than 140 mmHg averaged over 2 weeks OR post-dialysis systolic blood pressure greater than 130 mmHg averaged over 2 weeks\n\nExclusion Criteria:\n\n* HemoDialysis Vintage Less than 2 months\n* Pregnancy\n* Mean systolic blood pressure nadir \\\u003C95 mmHg in 2 weeks screening\n* Mean pre- or post-dialysis systolic blood pressure \\>180 mmHg\n* Mean pre to post-HD decrease in blood pressure \\>60 mmHg\n* Routine intradialytic clonidine use\n* Routine intradialytic midodrine use\n* Documented antihypertensive medication non-adherence\n* Mean ultrafiltration rate \\>13 mL\u002Fkg\u002Fhr during 2 week screening\n* For bioimpedance measurements only: amputation of a major extremity, presence of cardiac defibrillator or pacemaker, presence of a metallic implant (prosthetic joint)",{"count":170,"type":21},69,[24],"Kidney failure has been recognized as one of the most costly chronic conditions among United States Veterans. Approximately 13,000 Veterans develop kidney failure each year, and most require hemodialysis initiation. Hemodialysis patients suffer significantly increased risk of death and hospitalizations, and excessive body fluid is a major cause of this. While empiric aggressive fluid removal during dialysis is one approach to limit fluid overload, this can cause dangerous decreases in blood pressure during dialysis that independently contribute to the high death rate. In this study, I aim to test a new strategy that prescribes fluid removal based on a patient's recent blood pressure patterns during dialysis. This clinical trial will compare my strategy to standard care and assess the outcomes of overall blood pressure change between dialysis treatments in addition to the number of times the blood pressure becomes dangerously low during dialysis. Another aim is to determine how differences in the structure and function of the heart influence blood pressure during dialysis.",[174,175,176,27],"End Stage Renal Disease","Hypertension","Extracellular Volume Overload",[174,175,178,27,179],"Extracellular Volume","Bioimpedance Spectroscopy","2026-01-05",{"date":182,"type":41},"2026-01-07",{"date":184,"type":41},"2021-02-10",{"date":186,"type":21},"2026-07-01",{"name":188,"class":189},"VA Office of Research and Development","FED",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":49},"100501814","trial-of-variable-dialysate-bicarbonate-100501814","NCT05814146","Trial of Variable Dialysate Bicarbonate","Randomized, Controlled, Double-blind Trial of Lower Versus Higher Dialysate Bicarbonate in Hospitalized Maintenance Hemodialysis Patients","Inclusion Criteria:\n\n* prevalent end-stage renal disease, on maintenance HD \\> 90 days\n* age ≥ 18 years old\n* thrice weekly HD\n\nExclusion Criteria:\n\n* hemoglobin \\\u003C 8.0 g\u002FdL\n* pregnancy\n* any physical, mental or medical condition which limited the ability to provide written informed consent","120 Years",{"count":199,"type":21},141,[24],"QTc prolongation and premature ventricular contractions (PVCs) are common in hemodialysis (HD) patients and are associated with sudden cardiac death.\n\nIt is known that higher dialysate bicarbonate is associated with more QTc prolongation during HD sessions.\n\nThis study aims to assess the effects of lower (30 mEq\u002FL) versus higher (35 mEq\u002FL) dialysate bicarbonate in adult maintenance HD patients admitted to the hospital.\n\nThe investigators will randomly assign subjects to lower versus higher dialysate bicarbonate concentrations during their hospital stay for up to a maximum of six HD sessions or until their hospital discharge.",[203,27,204,205,206],"Peri-dialytic Cardiac Rhythms","Electrolyte Changes","pH Changes","Adverse Symptoms","2025-11-19",{"date":209,"type":41},"2025-11-24",{"date":211,"type":41},"2023-08-24",{"date":213,"type":21},"2026-10-01",{"name":215,"class":48},"Brigham and Women's Hospital",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":224,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":49},"100595501","inferior-vena-cava-collapsibility-index-and-intradialytic-hypotension-100595501","NCT07033273","Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension","The Predictive Value of the Inferior Vena Cava Collapsibility Index for Intradialytic Hypotension: A Prospective Multicenter Observational Stud","IVC-HD","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosed with end-stage renal disease (ESRD).\n* Undergoing regular hemodialysis for at least three months.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Hemodynamically unstable patients or those requiring vasopressor support.\n* Patients with severe cardiac conditions, including congestive heart failure -classified as NYHA Class III-IV or severe valvular disease.\n* Patients with known allergies to dialysis filters.\n* Dialysis sessions terminated for reasons unrelated to hypotension (e.g., technical issues, patient request).\n* Patients who withdraw informed consent during the study.\n* Use of antihypertensive medications during dialysis sessions.\n* Inability to undergo ultrasound assessment due to factors such as severe obesity or wounds obstructing access.",{"count":225,"type":21},188,"This multicenter, prospective observational study aims to evaluate the predictive value of the Inferior Vena Cava Collapsibility Index (IVCCI), along with IVC maximum diameter (IVCmax) and IVC minimum diameter (IVCmin), for intradialytic hypotension in patients undergoing maintenance hemodialysis. The study will be conducted at The First Affiliated Hospital of Wannan Medical College, Wuhu City Second People's Hospital, Wuhu Hospital of Chinese Traditional Medicine, Wuhu Jinghu District Hospital, and Wuhu Guangji Hospital. Eligible participants are adults aged 18 years or older with diagnosed end-stage renal disease (ESRD), receiving regular hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors likely to influence results will be excluded.\n\nUltrasound measurements of IVCCI, IVCmax, and IVCmin will be performed once, precisely at 1 hour after dialysis initiation. IVCmax will be measured during inspiration when the IVC is at its largest, and IVCmin during expiration when it is at its smallest. Blood pressure will be monitored continuously during the procedure. The primary objective is to assess the sensitivity, specificity, and optimal cutoff values of IVCCI, IVCmax, and IVCmin for predicting hypotension, aiming to provide a simple and non-invasive tool to facilitate personalized dialysis management and reduce intradialytic hypotension. A sample size of 188 participants is estimated, with data analyzed using ROC curves and multivariate regression methods. The study protocol adheres to ethical standards and regulatory requirements, demonstrating potential to improve patient safety and treatment outcomes.",[228,27],"End-Stage Renal Disease Requiring Haemodialysis",[27,93,230,231,232],"Inferior Vena Cava Collapsibility Index","Blood Pressure Prediction","Vascular Ultrasonography","2025-06-14",{"date":235,"type":41},"2025-06-24",{"date":237,"type":41},"2025-01-27",{"date":239,"type":21},"2025-07-31",{"name":241,"class":48},"First Affiliated Hospital of Wannan Medical College",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":250,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":49},"100595500","predictive-value-of-carotid-ultrasonography-for-intradialytic-hypotension-100595500","NCT07033260","Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension","The Predictive Value of Carotid Corrected Flow Time and Peak Flow Velocity Variability for Intradialytic Hypotension: A Prospective Multicenter Observational Study","CUPID","Inclusion Criteria:\n\nAdults aged 18 to 80 years. Diagnosed with end-stage renal disease (ESRD). Undergoing maintenance hemodialysis for more than three months. Willing and able to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\nPatients with significant carotid artery stenosis due to heavy atherosclerotic plaque (defined as more than 70% stenosis confirmed by ultrasound or angiography).\n\nHemodynamically unstable patients or those requiring vasopressor support. Patients with significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia).\n\nDialysis sessions terminated for reasons unrelated to hypotension (e.g., technical issues, patient request).\n\nUse of antihypertensive medications during dialysis sessions. Inability to undergo ultrasound assessment due to factors such as severe obesity or wounds obstructing access.\n\nPatients who withdraw informed consent during the study.",{"count":251,"type":21},183,"This multicenter, prospective observational study aims to evaluate the predictive value of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) for hypotension during maintenance hemodialysis. Conducted at The First Affiliated Hospital of Wannan Medical College, Wuhu City Second People's Hospital, Wuhu Hospital of Chinese Traditional Medicine, Wuhu Jinghu District Hospital, and Wuhu Guangji Hospital, the study will include adult patients (≥18 years) with end-stage renal disease (ESRD) on long-term hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors affecting results will be excluded. Ultrasound assessments of FTc and PFVV will be performed once, at 1 hour after dialysis initiation. Blood pressure will be monitored during the procedure. The primary outcome is to determine the sensitivity, specificity, and optimal cutoff points of FTc and PFVV in predicting intradialytic hypotension. The estimated sample size is 183 participants, with analysis performed using ROC curves and multivariate regression. The protocol complies with ethical standards and aims to develop a simple, non-invasive, real-time tool to improve patient safety and individualized management during hemodialysis.",[27,228,254,93],"Uremia; Chronic",[256,257,258,34,93,259,260,261,262],"Carotid ultrasonography","Corrected flow time","Peak flow velocity variability","Ultrasonographic predictors","Vascular ultrasonography","Fluid management","Dialysis safety",{"date":235,"type":41},{"date":265,"type":41},"2025-02-01",{"date":267,"type":21},"2025-08-30",{"name":241,"class":48},{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":85,"enrollmentInfo":277,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":279,"conditions":280,"keywords":282,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":293,"leadSponsor":295,"locationsCount":49},"100594699","pleth-variability-index-for-predicting-low-blood-pressure-during-maintenance-hemodialysis-100594699","NCT07022847","Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis","The Value of Pleth Variability Index in Predicting Hypotension During Maintenance Hemodialysis: A Prospective Observational Multicenter Study","PVI-HD","Inclusion Criteria:\n\n* Adults aged 18 to 80 years.\n* Diagnosis of end-stage renal disease and undergoing maintenance hemodialysis for more than 3 months.\n* Able and willing to provide informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Severe cardiac arrhythmias or significant peripheral vascular disease that may interfere with PVI measurements.\n* Local edema, skin lesions, or other conditions that prevent accurate PVI monitoring.\n* History of hemodynamic instability unrelated to dialysis.\n* Pregnant or breastfeeding women.\n* Known allergy or contraindication to materials used in the hemodialysis circuit.\n* Unable to cooperate with study procedures.\n* Participation in another interventional clinical study within the past 30 days.",{"count":278,"type":21},200,"What is this study about? We are studying whether the Pleth Variability Index (PVI)-a simple, non-invasive measurement from a pulse oximeter-can help predict low blood pressure (hypotension) during routine maintenance hemodialysis. Low blood pressure during dialysis is a common and potentially serious complication. Our goal is to find out if monitoring PVI can help identify patients at risk, so that early action can be taken.\n\nWho can join? Adults aged 18 to 80 years. Patients who have been receiving maintenance hemodialysis regularly for more than 3 months.\n\nThose who are willing and able to participate and sign an informed consent form.\n\nWho cannot join? Patients with severe heart rhythm problems, severe peripheral circulation problems, or swelling that makes PVI measurement unreliable.\n\nPatients who are pregnant or breastfeeding. Patients allergic to the dialysis filter or unable to cooperate with the study procedures.\n\nWhat will happen during the study? PVI Measurement: Your PVI will be checked with a simple fingertip device before starting dialysis and again 30 minutes after dialysis begins.\n\nBlood Pressure Monitoring: Your blood pressure will be closely watched throughout the dialysis session.\n\nData Collection: Information about your age, medical history, medications, lab results, dialysis settings, and other standard measurements will be recorded.\n\nWhat are the benefits and risks? Benefits: By identifying patients at higher risk for low blood pressure during dialysis, the study may lead to safer and more comfortable dialysis treatment in the future.\n\nRisks: All measurements used in this study are safe and non-invasive, with no extra risk compared to routine care.\n\nYour Rights and Safety Participation is completely voluntary-you may leave the study at any time without affecting your medical care.\n\nThe study has been reviewed and approved by the hospital's ethics committee. Your privacy and personal data will be strictly protected.",[281,93,228,27],"Hypotension and Shock",[283,93,27,284,285,286,287,288],"Pleth Variability Index","Blood Pressure Monitoring","End-Stage Renal Disease","Non-invasive Monitoring","Predictive Marker","Maintenance Dialysis","2025-06-07",{"date":291,"type":41},"2025-06-15",{"date":265,"type":41},{"date":294,"type":21},"2025-06-30",{"name":241,"class":48},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":22,"phases":304,"briefSummary":305,"conditions":306,"keywords":307,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":49},"100591476","phase-2-the-efficacy-and-safety-of-guilu-erxian-jiao-in-the-treatment-of-intradialytic-hypotension-100591476","NCT06980922","The Efficacy and Safety of Guilu Erxian Jiao in the Treatment of Intradialytic Hypotension","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Undergoing maintenance hemodialysis three times per week, 4 hours per session\n* History of intradialytic hypotension (IDH)\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Severe comorbid illness, such as cancer, stroke, or liver cirrhosis\n* Inability to comply with study medication regimen\n* Regular use of antihypertensive medication",{"count":303,"type":21},34,[116],"The goal of this clinical trial is to learn if Guilu Erxian Jiao, a traditional Chinese herbal medicine, can help manage intradialytic hypotension (IDH), a drop in blood pressure that occurs during hemodialysis in adults. The main questions it aims to answer are:\n\n1. Does Guilu Erxian Jiao reduce the frequency and severity of low blood pressure during dialysis?\n2. Is Guilu Erxian Jiao safe to use in patients receiving hemodialysis?\n\nResearchers will compare standard care plus Guilu ErXian Jiao to standard care alone to see if Guilu Erxian Jiao improves blood pressure stability during dialysis.\n\nParticipants will:\n\n1. Take Guilu Erxian Jiao once daily in addition to standard care, or receive standard care alone, for 4 weeks, then switch treatments after a 4-week washout period (crossover design).\n2. Undergo follow-up assessments at weeks 2 and 4 after each treatment phase.\n3. Have their blood pressure monitored before, during (hourly), and after each dialysis session.\n4. Report dialysis-related symptoms such as dizziness and fatigue.\n5. Receive routine laboratory tests and safety monitoring throughout the study.",[27,285,93],[27,93,308,309,310,285,311,312,313,314],"Traditional Chinese Medicine","Herbal Medicine","Guilu Erxian Jiao","Randomized Controlled Trial","Kidney Disease","Dialysis Complications","Blood Pressure","2025-05-19",{"date":317,"type":41},"2025-05-20",{"date":319,"type":21},"2025-06-01",{"date":321,"type":21},"2028-05-31",{"name":129,"class":48},{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":22,"phases":333,"briefSummary":334,"conditions":335,"keywords":337,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":4},"100585009","this-study-evaluates-the-impact-of-the-sodium-management-tool-smt-on-hemodialysis-patient-outcomes-compared-to-standard-care-100585009","NCT06896786","This Study Evaluates the Impact of the Sodium Management Tool (SMT) on Hemodialysis Patient Outcomes Compared to Standard Care","Sodium Management Tool in Hemodialysis Patients","SOMEDIA","Inclusion Criteria:\n\n* Outpatients on hemodialysis for at least three months,\n* Dialysis three times a week, age \\>\u002F= 18,\n* dialysis with a Fresenius 6008 Machine,\n* signed informed consent\n\nExclusion:\n\n* Dialysis access with repeated Interruption due to flow problems\n* plasma natrium \\\u003C 130 mmol\u002Fl, \\> 145 mmol\u002Fl, pregnancy -",{"count":332,"type":21},30,[24],"Title of the Study: Sodium Management Tool in Hemodialysis Patients\n\nBrief Summary:\n\nThe goal of this clinical trial is to learn whether the Sodium Management Tool (SMT) can improve patients clnical outcomes.\n\nThe main questions this study aims to answer are:\n\nDoes the SMT help reduce weight gain between dialysis sessions? Does the SMT improve dialysis tolerance by reducing symptoms like low blood pressure and muscle cramps?\n\nResearchers will compare standard dialysis to dialysis using the SMT to see if clinical outcomes are better in dialysis that use the SMT.\n\nParticipants will:\n\nReceive dialysis three times per week with either standard dialysis or SMT-activated dialysis Switch between standard dialysis and SMT-activated dialysis after 4 weeks Have their blood pressure, sodium levels, and symptoms monitored during treatment Report their symptoms and thirst levels in a questionnaire Some participants may continue for an additional 4 weeks with a personalized SMT setting based on their symptoms and weight changes.\n\nThis study will help determine whether the SMT can improve sodium balance and make dialysis more comfortable for patients.",[93,336,27],"Interdialytic Weight Gain",[338,339,340,341,342],"sodium management in hemodialyis patients","management of complaints in hemodialysis patients","interdialytic weight gain","intradialytic hypotension","sodium management tool","2025-03-19",{"date":345,"type":41},"2025-03-26",{"date":347,"type":21},"2025-04-01",{"date":349,"type":21},"2025-08-31",{"name":351,"class":48},"Sharon-Rose Maloney",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":358,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":368,"leadSponsor":370,"locationsCount":4},"100584504","effect-of-dialysate-cooling-versus-sodium-profiling-in-management-of-intradialytic-hypotension-among-chronic-hemodialysis-patients-100584504","NCT06890195","Effect of Dialysate Cooling Versus Sodium Profiling in Management of Intradialytic Hypotension Among Chronic Hemodialysis Patients","Inclusion Criteria:\n\n* • Patients age 18-70 years old.\n\n  * Maintained on HD for not less than 6 months\n  * Documented episodes of IDH\n\nExclusion Criteria:\n\n* • Severly anemic patients (Hb\\\u003C7 g\u002Fdl)\n\n  * Patients taking more than 3 antihypertensive (on days other than dialysis day).\n  * Patients with documented IHD.\n  * Patients on midodraine therapy prior dialysis session.\n  * patient refusal, incompliance or ineffective dialysis.","70 Years",{"count":360,"type":21},106,[24],"Chronic kidney disease (CKD) is a worldwide public health issue. Dialysis patients have a tenfold greater relative risk of cardiovascular death than the general population.\n\nDialysate cooling prevents intradialytic hypotension (IDH). This is achieved by inducing vasoconstriction and activating the sympathetic nervous and therefore improving hemodynamic stability .\n\nIntradialytic hypotension (IDH) is a common complication of HD. There is no consensus on the definition of IDH, but (IDH) is commonly defined as a drop in blood pressure during dialysis procedure and\u002F or hypotensive symptoms such as dizziness, weakness, nausea, cramps, blurred vision, and fatigue .\n\nThe pathophysiology of IDH is diverse. It could be the result of an inadequate cardiovascular response to the reduction in blood volume that occurs when the ultrafiltration volume is large . One process may involve an imbalance between a reduced effective circulating volume and the compensatory plasma refilling mechanism, wherein fluid from the interstitial and intracellular space is translocated into the intravascular compartment .\n\nCold dialysis reduces HD-induced brain damage by protecting the cerebral vascular beds from harmful perfusion . In the heart, long- term cold dialysis improved resting ejection fraction and reduced left ventricular mass and end-diastolic volumes while preserving aortic distensibility, decreasing the risk for future cardiovascular events\n\n. Risk factors associated with IDH include old age, female gender, Hispanic ethnicity, long dialysis vintage, high intradialytic weight gain, high dialysis dose, anemia, diabetes, low pre-dialysis BP, high osmolarity, and high body mass index .\n\nIt can be applied universally and reduce the need for nursing involvement . Further, no additional cost is needed to conduct fixed reduction of dialysate temperature. While there are various methods of reducing dialysate temperature, optimal temperature or methods of temperature reduction to prevent IDH remain uncertain\n\nTo study the effect of dialysate cooling (0.5- 1 C lower than pre- dialysis core body temperature) Vs traditional sodium profiling on:\n\n1. Reduction the episodes of IDH .\n2. Net dry weight achievements.\n3. Post dialysis fatigue.",[27],"2025-03-17",{"date":366,"type":41},"2025-03-21",{"date":347,"type":21},{"date":369,"type":21},"2026-08-01",{"name":371,"class":48},"Assiut University"]