50 Participants Needed

Bundle of Care for Kidney Transplant

(PDF Trial)

SD
Overseen ByStuart Dr. McCluskey, MD, PhD, FRCPC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 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.12345

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.56789

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.35101112

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.

Research Team

SD

Stuart Dr. McCluskey, MD, PhD, FRCPC

Principal Investigator

University Health Network, Toronto

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

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

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

Treatment Details

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.
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

Findings from Research

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

References

A Better Journey for Patients, a Better Deal for the NHS: The Successful Implementation of an Enhanced Recovery Program After Renal Transplant Surgery. [2018]
Care bundles: the holy grail of infectious risk management in hospital? [2021]
Care Bundles for Acute Kidney Injury: Do They Work? [2017]
Care bundle approach to reduce device-associated infections in a tertiary care teaching hospital, South India. [2020]
[CKD care in French nephrology practices]. [2022]
Usability of mobile technology to screen for drug-drug interactions in kidney transplant patients. [2014]
Finding a common language for patient safety in CKD. [2019]
Improved patient safety and outcomes with a comprehensive interdisciplinary improvement initiative in kidney transplant recipients. [2021]
Medication errors and adverse drug events in kidney transplant recipients: incidence, risk factors, and clinical outcomes. [2022]
Impact of the bundled end-stage renal disease payment system on patient care. [2012]
The effects of care bundles on patient outcomes: a systematic review and meta-analysis. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Care Bundles: Increasing Consistency of Care. [2018]
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