[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569543":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":56,"collaborators":24,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":24,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":24,"enrollmentInfo":68,"targetDuration":24,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":83,"whyStopped":24,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Manitoba","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Higher pre-dialysis blood pressure target (150-170 mm Hg systolic) (as a unit-level policy)","ACTIVE_COMPARATOR","The approach to reach blood pressure target is up to the treating physician. Depending on baseline pre-dialysis systolic blood pressure, blood pressure may need to be raised or lowered to reach the target.",[13,14],"Other: Increase systolic blood pressure","Other: Decrease systolic blood pressure",{"label":16,"type":17,"description":11,"interventionNames":18},"Lower pre-dialysis blood pressure target (110-140 mm Hg systolic) (as a unit-level policy)","EXPERIMENTAL",[13,14],[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Increase systolic blood pressure","To increase systolic blood pressure, treating physicians can consider the following options:\n\n1. Withdraw blood pressure medications, reducing dose of medications that are not indicated for other reasons, or down titrate medication.\n2. Increase estimated dry weight (EDW) by 0.5 kg increments if the participant is hypovolemic or euvolemic",[9,16],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Decrease systolic blood pressure","To decrease SBP, treating physicians can consider the following options:\n\n1. Adjust blood pressure medications. This could be accomplished by increasing the dose of current medications, and\u002For adding an additional medication class. Choice of medication will be dependent on current medications, contraindications, age, comorbidities, and cardiovascular indications. Adherence to blood pressure medications should be reviewed.\n2. Reduce EDW by 0.1 - 0.5 kg\n3. Reduce sodium levels. This could be accomplished through a reduction in dietary sodium intake to \\\u003C2 gm\u002Fday and fluid intake to \\\u003C1.5 L per day. Adherence to dietary sodium restrictions should be reviewed with the participant\n4. Extend dialysis time or adding an additional dialysis session if needed to achieve target dry weight",[9,16],[30],{"name":31,"affiliation":5,"role":32},"Navdeep Tangri, MD, PhD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Rachel Girimonte, MSc","CONTACT","204-632-3667","rgirimonte@sogh.mb.ca",{"name":40,"role":36,"phone":24,"phoneExt":41,"email":42},"Oksana Harasemiw, MSc","(204) 632-3541","oharasemiw@sogh.mb.ca",[44],{"facility":5,"status":24,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":24},"Winnipeg","Manitoba","R3T 2N2","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-97.14704,49.8844,{"lat":54,"lon":53},{"type":32,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Navdeep Tangri","Principal Investigator\u002FProfessor","100569543","feasibility-of-a-randomized-cluster-trial-for-blood-pressure-targets-in-in-centre-hemodialysis-units-100569543",false,"NCT06695611","Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis Units","Evaluating the Feasibility of a Randomized Cluster Trial for Blood Pressure Targets in In-centre Hemodialysis Units (BP in HD Pilot Trial)","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Undergoing in-centre hemodialysis at least twice weekly\n* \\> 90 days since initiation of dialysis\n\nExclusion Criteria:\n\n* Participation in another intervention study that may affect blood pressure other than other cluster RCTs of dialysate composition\n* Inability to measure blood pressures in an upper arm\n* Pregnancy, anticipated pregnancy, or breastfeeding\n* Unmeasurable SBP (e.g., have left ventricular assist device)\n* Life expectancy \\\u003C 4 months\n* Planned transition to home dialysis within 3 months\n* Planned move to a different dialysis unit within 3 months\n* Anticipated living donor kidney transplant within 3 months\n* Other reasons as determined by treating clinician, reasons will be recorded","ALL","18 Years",{"count":69,"type":70},60,"ESTIMATED","INTERVENTIONAL",[73],"NA","High blood pressure in people receiving hemodialysis is known to contribute to heart disease and heart-related death from strokes, heart failure, left ventricular hypertrophy (which is a thickening of the heart wall that makes it difficult for the heart to pump blood) and arrythmias (an irregular or abnormal heartbeat). In comparison, low blood pressure can lead to cramps, myocardial stunning, and cerebrovascular ischemia. However, despite, blood pressure management being an important component of hemodialysis care, the \"best\" blood pressure target for people on hemodialysis is unknown.\n\nFinding the \"right\" blood pressure to target can have a major impact on patient lives. We are proposing a large, pragmatic, cluster randomized trial targeting a lower versus higher blood pressure target in in-centre hemodialysis units in Canada. Our initial steps towards this bigger trial are to run a smaller trial including 4 units, to evaluate whether it is feasible to conduct a larger trial. Our ultimate goal is to deliver the definitive randomized trial for blood pressure targets in the hemodialysis population.",[76],"Chronic Kidney Disease 5D",[78,79,80,81,82],"Chronic Kidney Diseases","Blood Pressure","End Stage Renal Disease","Hemodialysis","Dialysis","NOT_YET_RECRUITING","2024-11-15",{"date":86,"type":87},"2024-11-19","ACTUAL",{"date":89,"type":70},"2025-02",{"date":91,"type":70},"2025-12",{"name":5,"class":6},1]