A pilot study to trial Normothermic EX vivo perfusion prior to Transplantation of the Kidney

Not Applicable

Recruiting

• Conditions: Renal failure; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12620000036910
• Lead Sponsor: Royal Australasian College of Surgeons

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-21
• Last Update Posted: 30 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Consenting adult recipients aged over 18 years who have been allocated a DCD kidney for Transplantation at Westmead Hospital NSW.

They must be able to understand the intervention which is being performed on the kidney, prior to it being transplanted into themselves and the potential complications and be able to give consent freely.

Exclusion Criteria

No paediatric recipient will be included in this trial. Patients who have either mental health or communication issues, such that they cannot consent or understand the trial will also be excluded. However both of these are usually a contraindication to transplantation, if they are unable to comply with standard post transplant care. Furthermore, patients undergoing their 3rd or more transplant or multi-organ transplantation will also be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility/implementation of normothermic machine perfusion of deceased donor kidneys prior to transplantation within the Australian setting.<br>[Up to 6 months post-transplant.]

Secondary Outcome Measures

Name	Time	Method
Delayed graft function defined as the need for dialysis within the first 7 days. This is assessed on clinical and biochemical grounds ie serum potassium, urea and creatinine levels, as well as clinical fluid overload.<br>[Need for dialysis within the first 7 post operative days];eGFR is assessed using CKD-EPI calculation based on gender, age and creatinine. Based on age, sex and serum biochemistry[1 month, 6 months and 1 year post transplant];Graft survival[1, 6, and 12 months post-transplant];Patient survival[1, 6, and 12 months post-transplant]