CArdiac Death kidney Machine Perfusion trial

ISRCTN	ISRCTN50082383
DOI	https://doi.org/10.1186/ISRCTN50082383
Protocol serial number	A092044 version 1.1
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funder	NHS Blood and Transplant (UK) (ref: UKT07/2)

Submission date: 05/04/2011
Registration date: 06/09/2011
Last edited: 23/11/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
There is an international shortage of kidneys for transplantation, and there is great interest in optimising the kidneys available, in order to ensure that kidney transplants last for as long as possible with the best long-term function. When kidneys are recovered from deceased donors they inevitably face a period of storage while they are shipped to the recipient hospital and the logistics of transplantation are put into place. It has been shown that this period of storage can be harmful to kidneys and so this study aims to test which of two commonly used storage techniques is best for kidney transplant outcome. The first technique is 'cold static storage' in which the kidney is placed in cold preservation solution and transported in a box of ice. The second is 'cold pulsatile machine perfusion' in which the kidney is placed on a machine that pumps preservation fluid around the kidney.

Who can participate?
Adult recipients of kidney transplants.

What does the study involve?
Kidneys for transplant will be randomly allocated to either be placed upon the pulsatile perfusion machine or placed in a standard cold-storage ice-box. The kidney transplant recipients will be asked if their information may be followed up.

What are the possible benefits and risks of participating?
Both kidney storage techniques are commonly used in clinical practice outside the study, and we do not anticipate any additional risks from taking part in the study over the standard risks of transplantation but, as many patients will require further transplants, the information gained from this study may help them in future.

Where is the study run from?
The study is being run from Cambridge, with patients from Leeds, Manchester, Edinburgh and Glasgow also taking part.

When is the study starting and how long is it expected to run for?
From April 2011 to May 2017.

Who is funding the study?
NHS Blood and Transplant (UK).

Who is the main contact?
Professor Chris Watson

Contact information

Prof Chris Watson
Scientific

Department of Surgery
Box 202
Addenbrooke's Hospital
Hill's Road
Cambridge
CB2 0QQ
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A multicentre randomised controlled study of machine perfusion on cardiac death donor kidneys
Study acronym	CAD-MP
Study objectives	Cold pulsatile machine perfusion reduces the incidence of delayed graft function in cardiac-death donor kidneys for transplantation, when compared to simple cold storage. On 26/06/2015 the overall trial end date was changed from 06/08/2012 to 01/12/2016.
Ethics approval(s)	National Research Ethics Service, Cambridgeshire 2 Research Ethics Committee, 08/03/2011, ref: 11/H0308/3
Health condition(s) or problem(s) studied	Kidney transplantion
Intervention	One kidney will be placed upon the LifePort pulsatile perfusion machine. The other will be placed in standard cold-storage ice-box
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Delayed graft function - the need for dialysis within the first week following transplantation
Key secondary outcome measure(s)	1. Duration of delayed graft function 2. The area under the curve of the daily serum creatinine level at days 1 to 14 3. Day 14 calculated estimated Glomerular Filtration Rate (eGFR) [abbreviated Modified Diet in Renal Disease (MDRD) technique] 4. The need for dialysis in the first 7 days excluding the first 24 hours post transplant 5. Median times to last dialysis 6. Non-graft function rates, defined as a kidney transplant that fails to provide one month of dialysis free renal replacement, where loss is not attributable directly to rejection or vascular thrombosis 7. Incidence of acute rejection 8. Three and twelve month graft survival 9. Three and twelve month serum creatinine 10. Three and twelve month glomerular filtration rate (MDRD method18) 11. Incidence of graft loss for technical reasons, e.g. renal artery or vein thrombosis 12. One year patient survival 13. Length of hospital stay
Completion date	31/05/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	270
Key inclusion criteria	1. Patients who receive a kidney transplant from a controlled or uncontrolled cardiac-death deceased donor 2. Recipient over the age of 18
Key exclusion criteria	1. Lack of informed consent 2. Positive crossmatch 3. Previous recipient of non-kidney solid-organ transplant
Date of first enrolment	06/04/2011
Date of final enrolment	01/12/2015

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Addenbrooke's Hospital

Cambridge
CB2 0QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		23/11/2018	23/11/2018	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN50082383_BasicResults_23Nov18.pdf: Uploaded 23/11/2018

Editorial Notes

23/11/2018: The basic results of this trial have been uploaded as an additional file.
18/12/2017: The overall trial end date was updated from 01/12/2016 to 31/05/2017.