Clinical trial NCT04619732: Real-time Monitoring of Kidney Grafts on Hypothermic Machine Perfusion
Official title: A Clinical Pilot Study Investigating the Real-time Dynamics of Glucose, Lactate and Creatinine Concentrations in Marginal Donor Kidneys Undergoing Hypothermic Machine Perfusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transplant;Failure,Kidney
Keywords: creatinine
microdialysis
Lead sponsor: Accunea Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Imperial College Healthcare NHS Trust
First posted: 2020-11-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A significant number of deceased donor kidneys donated for transplantation are not used and are thrown away due to lack of ways of checking their condition and function before the operation. This significantly reduces the number of potentially life saving transplants.

The researchers wish to run a small pilot study to see if it is possible to improve the way transplant kidneys are assessed before transplantation by measuring how well they filter the blood, and how good their metabolism is. The researchers believe this new method will help transplant surgeons make better decisions about which kidneys to use.

This pilot study will look at 10 kidneys obtained from older deceased donors. These kidneys are most at risk of being thrown away because of the condition of the donor they came from. At the hospital, these kidneys are usually put onto a machine which pumps cold preservation solution through them for a couple of hours. This time lets the transplant surgeons see how well or poorly the kidney responds to the flowing fluid.

In this study the research team will do exactly the same, but also insert a small probe less than a millimetre in diameter into the kidney and the vein (draining blood pipe) and urine output to monitor a number of chemicals made by the kidney. The researchers believe that the changing levels of these chemicals will give the surgeons much more information than they have now. This probe is removed when the kidney is transplanted.

Combining these levels with news of how well the patients recover after surgery will allow the research team to design a much larger study to get the right level of information to change the way surgeons choose kidneys and help more transplants happen in the future.


Eligibility criteria: Inclusion Criteria:

* All organs to be used in the study must be intended for transplantation and not already rejected/discarded.
* All organs must be sourced from deceased donors through NHSBT in the normal course of clinical activity.
* Kidneys must come from marginal or 'imperfect' donors according to current clinical criteria. This typically indicates an age of 60 and over, or 50 and over with one or more premorbid conditions, including renal impairment, cerebrovascular disease, and hypertension.

Exclusion Criteria:

* Organs from living donors are excluded.
* Organs from young healthy donors are excluded.
* Organs will be excluded if on the assessment of the clinical team they are not suitable for hypothermic machine perfusion. This indicates organs that have arrived with visible defects, or fall well outside the team's standard criteria for clinical acceptability (excessive time in transit, excessive warm ischaemia time, excessive cold ischaemia time, very poor pre-morbid donor condition).

Primary outcomes:
measure: Post-operative recovery of kidney function
timeFrame: 30 days post-operatively
Secondary outcomes:
measure: Reintervention rate
timeFrame: 30 days post-operatively
measure: Primary non-function
timeFrame: 30 days post-operatively
measure: Delayed graft function
timeFrame: 30 days post-operatively
measure: Acute rejection
timeFrame: 30 days post-operatively
measure: Post-operative complications
timeFrame: 30 days post-operatively
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Vassilios Papalois, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: