CArdiac Death kidney Machine Perfusion trial
| ISRCTN | ISRCTN50082383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50082383 |
| Secondary identifying numbers | A092044 version 1.1 |
- 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
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
Scientific
Department of Surgery
Box 202
Addenbrooke's Hospital
Hill's Road
Cambridge
CB2 0QQ
United Kingdom
Study information
| Study design | Multicentre randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 06/04/2011 |
| Completion date | 31/05/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Sequential trial design - maximum of 270 recipients |
| 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
- England
- United Kingdom
Study participating centre
CB2 0QQ
United Kingdom
Sponsor information
Hospital/treatment centre
Research And Development Department
Box 277
Addenbrooke's Hospital
Hill's Road
Cambridge
CB2 0QQ
England
United Kingdom
| Phone | +44 (0)12 2334 9321 ext 59321 |
|---|---|
| julie.taylor@addenbrookes.nhs.uk | |
| Website | http://www.cuh.org.uk/ |
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | To be confirmed at a later date |
| 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 |
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.
