[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571742":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":37,"responsibleParty":83,"collaborators":25,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":25,"enrollmentInfo":95,"targetDuration":25,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":108,"whyStopped":25,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","ACTIVE_COMPARATOR","Routine clinical care for kidney transplant patients",[13],"Other: Control Group",{"label":15,"type":16,"description":17,"interventionNames":18},"Surgical bundle","EXPERIMENTAL","The surgical bundle will consist of: the use of plasmalyte for fluid management, maintaining mean arterial pressure \\> 75 mmHg, identify and treat blood glucose \\> 9 mmol\u002FL, and a restrictive criteria for red blood cell transfusions (i.e. hemoglobin (Hb) \\\u003C 70 g\u002FL).",[19],"Other: Treatment bundle of care",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Treatment bundle of care","The treatment bundle of care will consist of: the use of plasmalyte for fluid management, maintaining mean arterial pressure \\> 75 mmHg, identify and treat blood glucose \\> 9 mmol\u002FL, and a restrictive criteria for red blood cell transfusions (i.e. hemoglobin (Hb) \\\u003C 70 g\u002FL).",[15],null,{"type":6,"name":9,"description":11,"armGroupLabels":27,"otherNames":25},[9],[29],{"name":30,"affiliation":5,"role":31},"Stuart Dr. McCluskey, MD, PhD, FRCPC","PRINCIPAL_INVESTIGATOR",[33],{"name":30,"role":34,"phone":35,"phoneExt":25,"email":36},"CONTACT","416-988-6233","Stuart.McCluskey@uhn.ca",[38,74],{"facility":39,"status":25,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University Health Network","Toronto","Ontario","M5G 2C4","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-79.39864,43.70643,{"lat":49,"lon":48},[52,53,56,58,60,62,64,66,68,70,72],{"name":30,"role":31,"phone":25,"phoneExt":25,"email":25},{"name":54,"role":55,"phone":25,"phoneExt":25,"email":25},"Ryan Dr. McGinn, MD, MSc, FRCPC","SUB_INVESTIGATOR",{"name":57,"role":55,"phone":25,"phoneExt":25,"email":25},"Wilton Dr. van Klei, MD, PhD",{"name":59,"role":55,"phone":25,"phoneExt":25,"email":25},"Anand Dr. Ghanekar, PhD, MD, FRCSC",{"name":61,"role":55,"phone":25,"phoneExt":25,"email":25},"Matthanja Dr. Bieze, MD, PhD",{"name":63,"role":55,"phone":25,"phoneExt":25,"email":25},"Joseph Dr. Kim, MD, FRCPC",{"name":65,"role":55,"phone":25,"phoneExt":25,"email":25},"Sonia Dr. Rodriguez-Ramirez, MD, FRCPC",{"name":67,"role":55,"phone":25,"phoneExt":25,"email":25},"Yanhong Li",{"name":69,"role":55,"phone":25,"phoneExt":25,"email":25},"Anna Santiago",{"name":71,"role":55,"phone":25,"phoneExt":25,"email":25},"Segum Famure",{"name":73,"role":55,"phone":25,"phoneExt":25,"email":25},"Jo Carrol",{"facility":39,"status":25,"city":40,"state":41,"zip":25,"country":43,"countryCode":44,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},{"type":46,"coordinates":76},[48,49],{"lat":49,"lon":48},[79,82],{"name":80,"role":34,"phone":35,"phoneExt":25,"email":81},"Stuart Dr. McCluskey, PhD, MD, FRCPC","stuart.mccluskey@uhn.ca",{"name":57,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":84,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100571742","preventing-delayed-graft-function-in-kidney-transplant-patients-100571742",false,"NCT06724211","Preventing Delayed Graft Function in Kidney Transplant Patients","Preventing Delayed Graft Function in Kidney Transplant Patients: A Single-centre, Randomised, Feasibility Trial","PDF","Inclusion Criteria:\n\n* ≥ 18 years\n* Patients undergoing kidney transplantation\n* Living and deceased donor recipients\n\nExclusion Criteria:\n\n* Multi-organ transplant\n* Pre-emptive KT\n* Arterial line not planned for surgery","ALL","18 Years",{"count":96,"type":97},50,"ESTIMATED","INTERVENTIONAL",[100],"NA","The health and quality of life benefits of kidney transplantation are reduced by delayed graft function (DGF). There are a number of modifiable risk factors associated with DGF, such as intraoperative hypotension, the type of intravenous fluid used, glycemic control, and the restriction of blood transfusions. However, these factors have been assessed individually, and their collective effect on reducing the risk of DGF requires further investigation. We first propose a pilot RCT to establish the feasibility of a definitive RCT examining the impact of a treatment bundle of care on DGF.\n\nThis will be a single centre, double-blinded pilot RCT including 50 adults undergoing kidney transplantation. Patients will be randomized to either the experimental group, which will consist of a treatment bundle of care, or to the control group, which will consist of routine clinical care for kidney transplant patients. The treatment bundle of care will consist of: the use of plasmalyte for fluid management, maintaining mean arterial pressure \\> 75 mmHg, identify and treat blood glucose \\> 9 mmol\u002FL, and a restrictive criteria for red blood cell transfusions (i.e. hemoglobin (Hb) \\\u003C 70 g\u002FL).\n\nThe primary outcome of this pilot study is the recruitment rate. Recruitment rate will be defined as the number of patients who are approached to participate in the study and who are randomized to either the experimental or control group, as a percentage of the total number of eligible kidney transplant patients. The secondary outcomes are: 1) protocol adherence rate and 2) follow-up rate. Protocol success will be defined as a ≥90% compliance with at least 3 of the 4 treatment bundle components. Patient follow-up will end at 90-days after transplant and the target is to follow ≥90% of the patients until this time. DGF and acute rejection will not be assessed in the feasibility trial, and instead this data will be analyzed in the full trial.",[103,104,105],"Kidney Transplant","Kidney Failure","Kidney Injury",[103,107],"Surgical Bundle","NOT_YET_RECRUITING","2024-12-05",{"date":111,"type":112},"2024-12-09","ACTUAL",{"date":114,"type":97},"2025-01-15",{"date":116,"type":97},"2026-04",{"name":5,"class":6},2]