Cold oxygenated machine preservation of aged renal donation after cardiovascular death transplants

A multicentre, double blind, randomised, parallel-group, paired trial to compare the effect of hypothermic machine perfusion preservation with and without the addition of oxygen in transplantation of Maastricht category III kidneys donated after circulatory death from donors aged 50 years or older

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN32967929

Enrollment

162

Registered

2013-12-11

Start date

2015-02-22

Completion date

Unknown

Last updated

2020-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Machine perfusion preservation techniques of kidney grafts Injury, Occupational Diseases, Poisoning

Interventions

Hypothermic machine perfusion (HMP) with and without the addition of oxygen. Group 1 ? control group: the kidney will be placed on the Kidney Assist HMP device and perfused with Belze

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Donors: 1. All potential consecutive Maastricht category III DCD donors aged 50 years or older from the collaborating donor regions Recipient: 1. At least 18 years old 2. Listed for renal transplantation due to end stage renal disease 3. Willingness to comply with the protocol procedures for the duration of the study

Exclusion criteria

Exclusion criteria: Donor: 1. An aortic patch too small for a reliable connection 2. Too many renal arteries preventing a safe connection Recipient: 1. Multi-organ transplantation 2. Planned dual kidney transplantation 3. The recipient is unable or unwilling to give informed consent

Design outcomes

Primary

Measure	Time frame
Kidney graft function as measured by a 24-hour creatinine clearance at 1 year after transplantation	—

Secondary

Measure	Time frame
1. Delayed graft function (DGF) - DGF defined as the need for dialysis (excluding one time dialysis for hyperkalaemia or fluid overload) within the first 7 days after kidney transplantation and preceding the return of kidney function. Functional DGF defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first week after transplantation, not including patients in whom acute rejection or calcineurin inhibitor toxicity is proven on biopsy. 2. Primary non function (PNF) defined as the permanent lack of function of the graft from time of transplantation until months post-transplant. This endpoint is determined post-hoc at 3 months post-transplant. 3. Biopsy proven acute rejection within first year post transplant. 4. Length of recipient hospital stay 5. Estimated glomerular filtration rate according to the 4-variable Modification of Diet in Renal Disease (MDRD) equation at 3 months, 6 months and 1 year after transplantation 6. 1 year graft (censored and uncensored for recipient death) survival 7. 1 year patient survival	—

Measure

Time frame

1. Delayed graft function (DGF) - DGF defined as the need for dialysis (excluding one time dialysis for hyperkalaemia or fluid overload) within the first 7 days after kidney transplantation and preceding the return of kidney function. Functional DGF defined as the absence of a decrease in the serum creatinine level of at least 10% per day for at least 3 consecutive days in the first week after transplantation, not including patients in whom acute rejection or calcineurin inhibitor toxicity is proven on biopsy. 2. Primary non function (PNF) defined as the permanent lack of function of the graft from time of transplantation until months post-transplant. This endpoint is determined post-hoc at 3 months post-transplant. 3. Biopsy proven acute rejection within first year post transplant. 4. Length of recipient hospital stay 5. Estimated glomerular filtration rate according to the 4-variable Modification of Diet in Renal Disease (MDRD) equation at 3 months, 6 months and 1 year after transplantation 6. 1 year graft (censored and uncensored for recipient death) survival 7. 1 year patient survival

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Countries

Belgium, Netherlands, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 1, 2026