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Limitation of Ischemic Injury of a Kidney Stored in Machine Perfusion in Hypothermia - Evaluation of the Impact on Kidney Allograft Function


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Transplanted Kidney Ischemia Reperfusion Injury

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Trial Information

Limitation of Ischemic Injury of a Kidney Stored in Machine Perfusion in Hypothermia - Evaluation of the Impact on Kidney Allograft Function


Inclusion Criteria:



DONOR STAGE

- donor after brain death

- seronegative HCV (hepatitis C virus)

- procurement of two kidneys from the same donor

- donor center distance up to 220 kilometres from Warsaw

- availability of fluid KPS-1 and cartridge of Organ Recovery System

RECIPIENT STAGE

- recipient of kidneys from deceased donor

- at least eighteen recipient

- expression of informed consent

Exclusion Criteria:

DONOR STAGE

- live kidney donor

- seropositive HCV (hepatitis C virus)

- get only one from the kidneys

- "doubtful" donor - e.g. need for biopsy because of proteinuria or due to histological
lesions (e.g. tumor)

- donor center distance above 220 kilometres from Warsaw

- lack of fluid KPS-1 and cartridge of Organ Recovery System

RECIPIENT STAGE

- recipient of kidney form living donor

- minor recipient

- no expression of informed consent

- multiple organ recipient

- recipient "EN BLOC" kidneys or two kidneys

- recipient of kidney from donor under 14 years old

- a need of atypical urinary diversion in kidney recipient

- participation in another study at least in the last 30 days

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

delayed graft function

Outcome Description:

a need at least one dialysis during first week after transplantation

Outcome Time Frame:

one week

Safety Issue:

No

Principal Investigator

Piotr Domagala, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical University of Warsaw

Authority:

Poland: Ethics Committee

Study ID:

N N403 589338-WUM-PD-Poland

NCT ID:

NCT01731457

Start Date:

April 2011

Completion Date:

March 2014

Related Keywords:

  • Transplanted Kidney Ischemia Reperfusion Injury
  • ischemia, reperfusion, kidney, transplantation
  • Hypothermia
  • Ischemia
  • Reperfusion Injury

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