Bundle of Care for Kidney Transplant
(PDF Trial)

Recruiting in Palo Alto (17 mi)

Overseen byStuart Dr. McCluskey, MD, PhD, FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

I am undergoing a kidney transplant.

Living and deceased donor recipients

I am 18 years old or older.

Exclusion Criteria

I have had a multi-organ transplant.

Arterial line not planned for surgery

I am getting a kidney transplant before starting dialysis.

Treatment Details

Interventions

Treatment bundle of care (Procedure)

Trial OverviewThe trial is testing a 'bundle of care' treatment to prevent delayed graft function after kidney transplants against routine care. The bundle includes specific fluid management, blood pressure control, blood sugar treatment, and restrictive blood transfusion criteria.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Surgical bundleExperimental Treatment1 Intervention

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/L, and a restrictive criteria for red blood cell transfusions (i.e. hemoglobin (Hb) \< 70 g/L).

Group II: Control GroupActive Control1 Intervention

Routine clinical care for kidney transplant patients