Preventing Delayed Graft Function in Kidney Transplant Patients

Summary

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.

Conditions

• Kidney Transplant
• Kidney Failure
• Kidney Injury

Interventions

OTHER

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

OTHER

Control Group

Routine clinical care for kidney transplant patients

Sponsors & Collaborators

• University Health Network, Toronto

  lead OTHER

Principal Investigators

• Stuart Dr. McCluskey, MD, PhD, FRCPC · University Health Network, Toronto

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-15

Primary Completion

2026-01-31

Completion

2026-04-30

Countries

• Canada

Study Locations