Bundle of Care for Kidney Transplant
(PDF Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.This 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/L, and a restrictive criteria for red blood cell transfusions (i.e. hemoglobin (Hb) \< 70 g/L).The 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is the Bundle of Care for Kidney Transplant generally safe for humans?
Research shows that a comprehensive care approach, including medication management and safety checks, can significantly reduce medication safety issues and improve outcomes for kidney transplant patients. This suggests that a well-coordinated care bundle can be safe and beneficial for patients.12345
How does the 'Bundle of Care for Kidney Transplant' treatment differ from other treatments for kidney transplants?
The 'Bundle of Care for Kidney Transplant' is unique because it involves a structured set of practices designed to improve care delivery and patient outcomes, similar to care bundles used in other conditions like sepsis. This approach focuses on consistency and reliability in treatment, which may not be as emphasized in traditional kidney transplant care.56789
What data supports the effectiveness of the treatment bundle of care for kidney transplant?
Care bundles, which are sets of practices done together, have been shown to improve patient outcomes in various conditions, like reducing infections and improving recovery after surgeries. This suggests that a bundle of care for kidney transplants could also enhance patient care and satisfaction.58101112
Who Is on the Research Team?
Stuart Dr. McCluskey, MD, PhD, FRCPC
Principal Investigator
University Health Network, Toronto
Are You a Good Fit for This Trial?
Adults over 18 years old undergoing kidney transplantation can participate. It's for those receiving kidneys from both living and deceased donors. People aren't eligible if they're getting multiple organ transplants, are having a pre-emptive kidney transplant, or won't have an arterial line during surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a perioperative bundle of care including plasmalyte for fluid management, maintaining mean arterial pressure > 75 mmHg, blood glucose control, and restrictive criteria for blood transfusions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Treatment bundle of care
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor