Bundle of Care for Kidney Transplant

(PDF Trial)

Overseen By Stuart Dr. McCluskey, MD, PhD, FRCPC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Multi-organ transplant, Pre-emptive KT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: During the intervention/procedure/surgery and immediately after

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special treatment bundle can reduce kidney problems after a transplant. The bundle includes using specific fluids, stabilizing blood pressure, managing blood sugar, and limiting blood transfusions. The goal is to determine if these combined steps improve recovery after a kidney transplant. Ideal participants are adults receiving a kidney transplant.

As an unphased trial, this study allows participants to contribute to innovative research that could enhance transplant recovery for future patients.

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.

What prior data suggests that this treatment bundle of care is safe for kidney transplant patients?

Research has shown that a specific set of care practices can be safe for kidney transplant patients. One study found that a similar approach reduced the risk of infections after a transplant, suggesting it might help prevent some complications. In this trial, the care set includes using a special fluid called Plasmalyte, managing blood pressure, controlling blood sugar, and limiting blood transfusions. These practices align with existing medical guidelines, supporting their safety. Although direct evidence from this trial is not yet available, these practices have been used safely in other medical situations. However, more data is needed to fully confirm their safety when used together in this way. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's testing a new surgical care bundle for kidney transplant patients that could improve outcomes. This bundle includes using Plasmalyte for better fluid management, maintaining a high mean arterial pressure, managing high blood sugar levels, and applying a restrictive policy for blood transfusions. These elements aim to enhance recovery and reduce complications compared to routine care, potentially setting a new standard for patient management after kidney transplants.

What evidence suggests that this treatment bundle of care is effective for reducing delayed graft function in kidney transplant patients?

This trial will compare a special care plan, known as the surgical bundle, with routine clinical care for kidney transplant patients. The surgical bundle includes specific steps such as using a fluid called plasmalyte, maintaining blood pressure above 75 mmHg, controlling high blood sugar, and reducing blood transfusions. Previous studies have found that similar care plans lower the risk of infections after a transplant. Specifically, patients who received this type of care experienced fewer infections than those who did not. This suggests that the care plan might help reduce complications after a kidney transplant. ^{1 2 5 6 7}

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

I am undergoing a kidney transplant.

Living and deceased donor recipients

Exclusion Criteria

I have had a multi-organ transplant.

Arterial line not planned for surgery

I am getting a kidney transplant before starting dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

During the intervention/procedure/surgery and immediately after

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Treatment bundle of care

Trial Overview The 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.

How Is the Trial Designed?

Group I: Surgical bundle Experimental Treatment 1 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 Group Active Control 1 Intervention

Routine clinical care for kidney transplant patients

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

The enhanced recovery program for renal transplant patients significantly reduced postoperative morphine requirements (median of 9.5 mg vs 47 mg in traditional recovery), indicating better pain management and potentially improved patient comfort.

Patients in the enhanced recovery group had a shorter hospital stay (median of 5 days for living donors and 5 days for deceased donors) compared to traditional recovery (7 days and 8.5 days, respectively), leading to substantial cost savings and high patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Better Journey for Patients, a Better Deal for the NHS: The Successful Implementation of an Enhanced Recovery Program After Renal Transplant Surgery. Halawa, A., Rowe, S., Roberts, F., et al.[2018]

The introduction of sepsis care bundles has been shown to significantly reduce the risk of sepsis, with a relative risk reduction exceeding 25% and an absolute risk reduction of over 9%, indicating a strong potential for improving patient outcomes.

Care bundles, particularly in the context of preventing infections like ventilator-associated pneumonia and catheter-associated bloodstream infections, have demonstrated effectiveness in multicenter studies, suggesting they can enhance the reliability of evidence-based care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care bundles: the holy grail of infectious risk management in hospital? Marwick, C., Davey, P.[2021]

Chronic kidney disease (CKD) that does not require dialysis significantly increases the risk of adverse safety events, which can lead to poor patient outcomes, highlighting the need for better safety measures in CKD care.

Medication errors are prevalent in CKD patients and contribute to safety lapses, indicating that a standardized set of disease-specific safety indicators is essential for improving patient safety and outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Finding a common language for patient safety in CKD. Fink, JC., Joy, MS., St Peter, WL., et al.[2019]

In a study of 476 kidney transplant recipients, 8% experienced clinically significant medication errors, which were linked to higher rates of acute rejection, infections, and readmissions.

Risk factors for these medication errors included being female, African-American, having pretransplant diabetes, experiencing delayed graft function, and being a retransplant recipient, highlighting the need for targeted interventions in these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication errors and adverse drug events in kidney transplant recipients: incidence, risk factors, and clinical outcomes. Taber, DJ., Pilch, NA., Bratton, CF., et al.[2022]

Citations

1. withpower.com withpower.com/trial/bundle-of-care-for-kidney-transplant-5c957

Bundle of Care for Kidney Transplant (PDF Trial) 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11666872/

Novel intervention based on an individualized bundle of care ... The 12‐month incidence of post‐transplant infection was significantly lower in the intervention group than in the preintervention cohort (42.6% [63/148] vs.

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/11/NCT06724211/Prot_SAP_000.pdf

Study Protocol PDF Trial Study working title: Version 1.0 / ... This pilot study seeks to assess whether we can recruit kidney transplant patients for an RCT and assess compliance to a surgical care bundle ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1600613522016641

Case Mix, Quality and High-Cost Kidney Transplant Patients Among 43 393 kidney transplants in Medicare recipients, 35.2% were categorized as high-cost patients. These payments represented 20% of total Medicare payments ...

5. journals.lww.com journals.lww.com/transplantationdirect/fulltext/2025/02000/persistent_mortality_risk_from_device_related.4.aspx

Persistent Mortality Risk From Device-related... The 90-d survival rate was significantly lower in patients with d-HAIs (37.7% versus 71.7%; P < 0.001). The bundle implementation reduced the risk of d-HAIs by ...

6. jopan.org jopan.org/article/S1089-9472(25)00051-6/abstract

Implementing a Care Bundle to Prevent Inadvertent ... The implementation of care bundles based on evidence-based practices was successful in identifying practical deficiencies in hypothermia ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2468024924000937

A Transplant-Inclusive Value-Based Kidney Care Payment ... Prior experience with a narrow focus on 1-year patient and graft survival outcomes resulted in reduced transplant rates, more waitlist removals, ...