Preventing Delayed Graft Function in Kidney Transplant Patients

NCT06724211 | Not Yet Recruiting

• 1 other identifier: 24-5286
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Kidney Transplant; Surgical Bundle

Outcome Measures

Primary Outcomes (1)

• 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 treatment or routine clinical care group, as a percentage of the total number of eligible transplant patients. In order to complete a full multicenter trial in a reasonable time period (2-3 years), the number needed to recruit per week is at least 1 patient, but we will aim to recruit 2 patients per week.

  Baseline, pre-intervention/procedure/surgery

Secondary Outcomes (2)

• Protocol adherence

  During the intervention/procedure/surgery AND immediately after the intervention/procedure/surgery

• Follow-up rate

  90-days after final patient recruited

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Routine clinical care for kidney transplant patients

Other: Control Group

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

Other: Treatment bundle of care

Interventions

Treatment bundle of care OTHER

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).

Surgical bundle

Control Group OTHER

Routine clinical care for kidney transplant patients

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years
• Patients undergoing kidney transplantation
• Living and deceased donor recipients

You may not qualify if:

• Multi-organ transplant
• Pre-emptive KT
• Arterial line not planned for surgery

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

Related Publications (2)

• Sicova M, McGinn R, Emerson S, Perez P, Gonzalez R, Li Y, Famure O, Randall I, Mina DS, Santema M, Wijeysundera DN, Van Klei W, Kim SJ, McCluskey SA. Association of Intraoperative Hypotension With Delayed Graft Function Following Kidney Transplant: A Single Centre Retrospective Cohort Study. Clin Transplant. 2024 Oct;38(10):e70000. doi: 10.1111/ctr.70000.

  PMID: 39460628 RESULT

• Pascoe EM, Chadban SJ, Fahim MA, Hawley CM, Johnson DW, Collins MG; BEST-fluids Investigators and the Australasian Kidney Trials Network. Statistical analysis plan for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a randomised controlled trial of the effect of intravenous fluid therapy with balanced crystalloid versus saline on the incidence of delayed graft function in deceased donor kidney transplantation. Trials. 2022 Jan 18;23(1):52. doi: 10.1186/s13063-021-05989-w.

  PMID: 35042554 RESULT

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Stuart Dr. McCluskey, MD, PhD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuart Dr. McCluskey, MD, PhD, FRCPC

CONTACT

416-988-6233; Stuart.McCluskey@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 9, 2024
• Study Start: January 15, 2025
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)