Condition category
Surgery
Date applied
05/04/2011
Date assigned
06/09/2011
Last edited
26/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 December 2016.

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

Who is the main contact?
Professor Chris Watson

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chris Watson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A092044 version 1.1

Study information

Scientific title

A multicentre randomised controlled study of machine perfusion on cardiac death donor kidneys

Acronym

CAD-MP

Study hypothesis

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

National Research Ethics Service, Cambridgeshire 2 Research Ethics Committee, 08/03/2011, ref: 11/H0308/3

Study design

Multicentre randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Delayed graft function - the need for dialysis within the first week following transplantation

Secondary outcome measures

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

Overall trial start date

06/04/2011

Overall trial end date

01/12/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Sequential trial design - maximum of 270 recipients

Participant exclusion criteria

1. Lack of informed consent
2. Positive crossmatch
3. Previous recipient of non-kidney solid-organ transplant

Recruitment start date

06/04/2011

Recruitment end date

01/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Research And Development Department
Box 277
Addenbrooke's Hospital
Hill's Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)12 2334 9321 ext 59321
julie.taylor@addenbrookes.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.cuh.org.uk/

Funders

Funder type

Government

Funder name

NHS Blood and Transplant (UK) (ref: UKT07/2)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes