[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SeaStar Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":106},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100555878","quelimmune-scd-ped-pediatric-surveillance-registry-100555878",false,"NCT06517810","QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry","Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children With Acute Kidney Injury: A Humanitarian Device Exemption (HDE) Surveillance Registry Protocol","SAVE","Inclusion Criteria:\n\n* All patients initiated on QUELIMMUNE therapy under the HDE-approved indication\n\nExclusion Criteria:\n\n* Weight \\\u003C10kg\n* Age \\>22 years\n* Known allergy to any components of QUELIMMUNE","ALL","22 Years",{"count":20,"type":21},50,"ESTIMATED","90 Days","OBSERVATIONAL","QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.\n\nThe purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE",[26,27],"Acute Kidney Injury","Acute Kidney Injury Due to Sepsis",[29,30,31,32,33,34],"continuous kidney replacement therapy","continuous renal replacement therapy","acute kidney injury","organ failure","inflammation","dialysis","RECRUITING","2026-05-11",{"date":38,"type":39},"2026-05-14","ACTUAL",{"date":41,"type":39},"2024-07-19",{"date":43,"type":21},"2026-08",{"name":45,"class":46},"SeaStar Medical","INDUSTRY",15,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100497502","neutrophil-and-monocyte-deactivation-via-the-selective-cytopheretic-device---a-randomized-clinical-trial-in-acute-kidney-injury-100497502","NCT05758077","Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury","A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients With Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy","NEUTRALIZE-AKI","Inclusion Criteria:\n\n* Admitted to an ICU requiring CKRT:\n\n  1. Must have AKI stage 2 or greater at the time of CKRT initiation.\n  2. Must have been on CKRT for at least 12 hours but no greater than 48 hours at the time of enrollment.\n* At least 18 years of age but not older than 80 at the time of enrollment.\n* One additional life-threatening organ dysfunction present.\n* Acceptable vascular access for CKRT to include adequate lumen size and length of catheters.\n* Initial (non-binding) commitment to maintaining current level of care for at least 96 hours.\n* C-Reactive Protein \\>3.5 mg\u002Fdl.\n\nExclusion Criteria:\n\n* Not expected to survive next 24 hours.\n* Anticipated transition to comfort measures or hospice in next 4 days.\n* Terminal condition whereby the patient is not expected to survive 28 days or any condition in which therapy is regarded as futile by the PI.\n* Advanced malignancy which is actively being treated or may be treated with palliative chemotherapy or radiation.\n* ICU hospitalization \\> 14 days during this hospital admission (to include days spent at ICU of an outside hospital) at the time of screening.\n* Active COVID-19 infection with a primary admission diagnosis of COVID-19.\n* Chronic use of ventricular assist devices.\n* ESRD requiring chronic kidney replacement therapy.\n* History of CKD (greater than Stage 3).\n* AKI stage 0 or stage 1 at the time of CKRT initiation.\n* Non-ATN AKI diagnosis. We intend on relying on local nephrology subspecialty expertise to reasonably exclude non-ATN diagnoses based on clinical suspicions combined with prespecified objective criteria. If there is a reasonable suspicion that the subject has non-ATN AKI based on this, they will be excluded from the trial.\n* Acute coronary syndromes, acute stroke, or acute major vascular compromise requiring medical or surgical interventions within 48 hours of randomization.\n* Active hemorrhage requiring blood transfusions at the time of screening.\n* Acute on Chronic Liver Failure.\n* Suspicion of hepato-renal syndrome.\n* Presence of any solid organ transplant at any time prior to admission.\n* Severe burns with a modified Baux score \\> 100 (%TBSA+Age+17 for Inhalation Injury).\n* Bone marrow transplant within the last year.\n* Chronic immunosuppression with an average of \\>20 mg\u002Fday of prednisone or other steroid sparing immunosuppressants for the past 30 days prior to hospital admission.\n* Individuals who have a history of primary or secondary immune disorders including, but not limited to, HIV or AIDS.\n* Dry weight of \\>150kg.\n* Platelet count \\\u003C15,000\u002Fmm3.\n* Patient is a prisoner or member of a vulnerable population.\n* Patient is pregnant or breast feeding.\n* Concurrent enrollment in another interventional clinical trial for an investigational drug or device.\n* Need for plasmapheresis.","18 Years",{"count":58,"type":21},339,"INTERVENTIONAL",[61],"NA","This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI. This study will enroll approximately 339 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.",[26],[29,30,31,32,33,34,65],"acute tubular necrosis","2026-04-20",{"date":68,"type":39},"2026-04-23",{"date":70,"type":39},"2023-04-17",{"date":72,"type":21},"2027-06",{"name":45,"class":46},38,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":59,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100349951","feasibility-of-the-scd-in-cardiorenal-syndrome-patients-awaiting-lvad-100349951","NCT03836482","Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD","Feasibility Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat ICU Patients With Acute on Chronic Systolic Heart Failure With Worsening Renal Function Due to Cardiorenal Syndrome or Severe Right Ventricular Failure Awaiting Left Ventricular Assist Device Implantation","NEUTRALIZE-CRS","Inclusion Criteria:\n\n1. Age of 18 years and older.\n2. Evidence of systemic inflammation: blood CRP ≥ 4.5 mg\u002FL or IL-6 ≥ 5.0 pg\u002Fml or neutrophil to lymphocyte ratio ≥3.0.\n3. Primary hospitalization for acute decompensated chronic systolic heart failure.\n4. Potential LVAD candidate with:\n\n   a) Left ventricular ejection fraction ≤25% (for potential destination therapy) or ≤ 35% (for potential bridge to transplantation) as confirmed by baseline imaging procedure b) NYHA class IIIB or IV chronic (≤ 90 days) systolic heart failure, with failure to respond to optimal medical therapy (beta blocker, ACE inhibitor or ARB or valsartan\u002Fsacubitril, aldosterone antagonist, SGLT2i, unless not tolerated or contraindicated, and loop diuretic, as needed) for 45 of the last 60 days c) Known previous peak exercise oxygen consumption \\\u003C 14 mL\u002FKg\u002Fmin or if unable to exercise, dependent on an intra-aortic balloon pump, short-term mechanical circulatory support device or intravenous inotropes unless inotropes contraindicated for clinical reasons (e.g., ventricular arrhythmias)\n5. Baseline eGFR\\*\\* ≥ 40 ml\u002Fmin\u002F1.73 m2 (baseline defined as the highest known eGFR within 90 days of study enrollment)\n6. At least one of the following two criteria:\n\n   1. Severe right ventricular failure (RVF), defined as meeting at least 2 of the following 4 criteria -Central venous pressure \\> 16 mmHg\n\n      -Central venous pressure\u002FPulmonary wedge pressure \\>0.65\n\n      -Right ventricular stroke work index \\\u003C 300 mmHg \\* ml\u002Fm2\n\n      -Pulmonary artery pulsatility index (PAPi) \\\u003C 2,\n   2. Worsening renal failure (WRF), defined for the purposes of this study as -Increase serum creatinine ≥ 0.5 mg\u002FdL from baseline (baseline defined as the lowest known serum creatinine within 90 days of study enrollment) AND\n\n      * eGFR\\*\\* ≤ 30 ml\u002Fmin\u002F1.73 m2 based on serum creatinine at enrollment\\*\\*\\* AND\n      * Cardiorenal syndrome is the most likely explanation for WRF AND\n      * Intolerant or inadequately responsive to standard of care diuretic therapy, defined as persistent signs and\u002For symptoms of congestion (e.g., peripheral edema, dyspnea, pulmonary rales, neck vein distension) or minimal net volume removal in a 24-hour period despite optimal medical therapy including intravenous diuretic therapy and an estimated need for \\>5kg fluid removal.\n\n        1. Optimal intravenous diuretic therapy is defined as:\n\n           1. Furosemide equivalent total daily dose of 240mg\n           2. Furosemide equivalent dose given either as a single or multiple intravenous bolus or continuous infusion\n           3. A furosemide equivalent total daily dose \\\u003C240mg if the dose has resulted in \\>3000 mL urine output\u002F24 hours.\n7. PA catheter in place at the time of enrollment\n8. PCW ≥ 20 mmHg\n\n   * eGFR calculated using the CKD-EPI Creatinine Equation \\*\\*\\* Recognizing that this is not a steady state creatinine\n\nExclusion Criteria:\n\n1. Any clear contraindication to LVAD therapy that is unlikely to resolve with improvement in renal function and volume status\n2. Prior sensitivity to dialysis device components\n3. Active bacteremia\n4. Temperature ≥ 101.5 F or WBC ≥ 10,000 K\u002FuL or any patient with suspected systemic infection.\n5. Metastatic malignancy requiring palliative chemo, biologic, or radiation\n6. Need for intravenous vasopressor (i.e., phenylephrine, vasopressin), intravenous vasoconstricting inotrope (i.e., norepinephrine or epinephrine) or dopamine \\> 3 mcg\u002Fkg\u002Fmin. (Note: use of vasodilating inotropes \\[i.e., dobutamine and milrinone\\] or dopamine at ≤ 3 mcg\u002Fkg\u002Fmin will not preclude study inclusion)\n7. Patients requiring mechanical ventilatory support\n8. Patients requiring total parenteral nutrition during the treatment period\n9. Persistent SBP \\\u003C 80 mmHg\n10. WBC \\\u003C 4000 K\u002FuL\n11. Platelets \\\u003C 100,000K\u002FuL\n12. Serum creatinine \\> 4 mg\u002FdL or receiving dialysis \u002F CRRT\n13. Acute coronary syndrome within the past month\n14. Women who are pregnant, breastfeeding a child, or trying to become pregnant\n15. Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical studies where only measurements and\u002For samples are taken (i.e., no test device or test drug used) are allowed to participate\n16. Use of any other investigational drug or device within the previous 30 days. Patients who participated in a clinical study where only measurements and\u002For samples are taken (i.e., no test device or drug used) are allowed to participate.",{"count":84,"type":21},20,[61],"Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system but also the renal, neuroendocrine, and immune systems. No effective therapy is currently available to treat the most severe subset of CHF patients that have progressed to acute decompensated HF. An innovative approach to reduce the cardio-depressant effects associated with the chronic inflammatory state of CHF may provide a breakthrough for this disorder. This proposal will evaluate the safety and probable benefit to improve cardiac or renal function with an immunomodulatory device to bridge patients to Left Ventricular Assist Device (LVAD) implantation who were previously deemed ineligible for this life sustaining procedure. The Selective Cytopheretic Device (SCD) is an immuno-regulating, extracorporeal membrane device targeted to modulate the cardiodepressant effects assocaited with CHF. SCD is a platform technology focused on immunomodulation of acute and chronic inflammation associated with acute and chronic organ dysfunction. SCD membranes selectively sequester activated systemic leukocytes as they flow through the cartridge via an extracorporeal circuit. Pre-clinical results show that SCD treatment results in a 25% improvement in ejection fraction in a canine CHF model.\n\nThis study will enroll 20 patients across up to 5 clinical sites to evaluate the safety and initial efficacy data of SCD treatment in this indication. Patients will receive 4-hour daily SCD treatment for up to 6 days, followed by 6 months of follow up.",[88,89],"Acute on Chronic Systolic Congestive Heart Failure","Cardiorenal Syndrome",[91,92,93,94,95,96],"Awaiting Left ventricular assist device implantation","Hospitalized","Selective Cytopheretic Device","SCD","LVAD","CRS","2026-03-30",{"date":99,"type":39},"2026-03-31",{"date":101,"type":39},"2025-10-02",{"date":103,"type":21},"2027-08",{"name":45,"class":46},1,""]