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 May 2017.
Who is funding the study?
NHS Blood and Transplant (UK).
Who is the main contact?
Professor Chris Watson
Trial website
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 measure
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
31/05/2017
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
See additional file (ISRCTN50082383_BasicResults_23Nov18.pdf)
Publication list
Publication citations
Additional files
- ISRCTN50082383_BasicResults_23Nov18.pdf Uploaded 23/11/2018