An interventional study of Procedure control: normothermia and Procedure active in Organ Donor, Brain Death and Kidney Transplant; Complications, sponsored by Nantes University Hospital. Completed at 54 sites in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Other
Each year, only one third of patients registered on the waiting list receive a kidney transplant. Numerous paths are being explored with the aim of reversing this shortage. The first is to increase the number of organs by developing harvesting from donors in a state of brain-death (BD) termed "expanded criteria donors" or from patients deceased from circulatory arrest.
Another fundamental factor is to insure the success of the transplant by limiting the dysfunction of donor kidneys, marked by a delayed graft function (DFG).
The development of techniques to insure correct perfusion of harvested organs, and the optimization of reanimation and intensive care of brain-dead donors constitute important factors in DGF reduction.
Therapeutic Hypothermia could to be an attractive care strategy for BD patients.
For donors: legal determination of death by neurologic criteria/deceased organ donor/no medical contre-indication to donation/Information given to the authorizing surrogate/ Pregnant women.
Exclusion Criteria:
After information for donation and research has been explained, organ donors in the normothermia (NT) group will either be maintained to spontaneously reach a body temperature of 36,5 °C-37,5°, until transfer to the operating room.
Procedure: Procedure control: normothermia
The intervention will take place after information for donation and research has been explained . Organ donors in the intervention group will either be actively warmed or allowed to reach a body temperature of 34 °C-35°C, until transfer to the operating room.
Procedure: Procedure active
Temperature will be maintained between 36.5° and 37.5°C in the control group. In case of temperature superior to 37.5°C or inferior to 36.5°C, a pharmaceutical treatment and/or active cooling or warming will be introduce to maintain temperature between the range of 36.5 - 37.5°C.
Also known as: Normothermia
Therapeutic hypothermia ie targeted controlled temperature between 34° and 35°C will be induced in the active group. Usual method of controlled temperature will be used in ICU: internal active method or external active method.
Also known as: Therapeutic hypothermia/ Induce hypothermia
rate of patients with delayed graft function (DGF)
DGF is the recipient's requirement for dialysis during the first week after transplantation. To show the interest of Targeted Temperature Management in order to optimize the functional recovery of transplanted kidney transplants by comparing 2 groups of recipient subjects: those receiving one Graft from an "expanded criteria donors" maintained in hypothermia (34°-35°) and those receiving a graft from an "expanded criteria donors" maintained in normothermia (36,5°-37,5°).
Time frame: Day 7
Temperature Profile
comparison of temperature profile between the two arms
Time frame: 24 hours
Severe arrhythmias
Severe arrythmia will be define by salvo of ventricular extrasystole, ventricular fibrillation, ventricular tachycardia, need an external shock, need anti-arrhythmic treatment. Participants will be followed for the duration of Intensive Care Unit stay and/or operating room, an expected average of 24 hours.
Time frame: 24 hours
Cardiac arrest
SParticipants will be followed for the duration of Intensive Care Unit stay and/or operating room, an expected average of 24 hours.
Time frame: 24 hours
Occurrence of hypotension measured by Total dose of inotropic drugs
Total dose of different inotropic drugs (Epinephrine, Norepinephrine, Dobutamine) will be compare between 2 groups during targetted controlled temperature management period.
Time frame: 24 hours
Occurrence of hypotension measured by cumulative fluid balance
Cumulative fluid balance will be compare between 2 groups during targetted controlled temperature management period
Time frame: 24 hours
occurrence of cardiac arrest
comparison of occurrence of cardiac arrest between the two arms
Time frame: 24 hours
Kidney function measured by serum creatinine value
Kidney function measured by serum creatinine value
Time frame: 24 hours
Kidney function measured by CKD EPI score
Kidney function measured by CKD EPI score (= 141 x min(Scr/K,1)a x max(Scr/K,1)-1,209 x 0,993Age x 1,018 (for women))
Time frame: 24 hours
electrolyte balance : potassium, calcium, sodium concentration disorders in mmoL/L
Potential hypothermia related side effects
Time frame: 24hours
glycemia in mmoL/L
Potential hypothermia related side effects
Time frame: 24hours
liver disorder (ASAT, ALAT, GGT, PAL , BILI in UI/L )
Potential hypothermia related side effects
Time frame: 24hours
thrombocytopenia in mm3/L
Potential hypothermia related side effects
Time frame: 24hours
Number of individual organs transplanted
Participants will be followed for the duration of Intensive care unit length of stay, and operating room, an average of 24 hours.
Time frame: 24 hours
Hospital mortality
Participants will be followed for the duration of hospital stay, an expected average of 1 week.
Time frame: Day 7
Kidney function measured by serum creatinine value
Kidney function measured by serum creatinine value at day7
Time frame: Day 7
Kidney function measured by CKD EPI
Kidney function measured by CKD EPI (= 141 x min(Scr/K,1)a x max(Scr/K,1)-1,209 x 0,993Age x 1,018 (for women))
Time frame: Day 7
Extra renal support requirement
Extra renal support requirement at Day7
Time frame: Day 7
Kidney graft acute rejection
Kidney graft acute rejection
Time frame: Day 7
Acute pulmonary oedema by left ventricular failure
Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days.
Time frame: Day 7
Severe arrythmia
Severe arrythmia will be define by salvo of ventricular extrasystole, ventricular fibrillation, ventricular tachycardia, need an external shock, need anti-arrhythmic treatment. Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days
Time frame: Day 7
Pulmonary embolism
Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days
Time frame: Day 7
Acute coronary syndrome
Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days
Time frame: Day 7
Nosocomial Bloodstream infection
Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days
Time frame: Day 7
Early onset pneumonia
Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days
Time frame: Day 7
Central Venous Catheter infection
Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days
Time frame: Day 7
Urinary tract sepsis
Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days
Time frame: Day 7
Mortality at D28
comparison of mortality at D28 between the two arms
Time frame: D28
Mortality at 3 months
comparison of mortality at 3months between the two arms
Time frame: 3 months
Mortality at 1 year
comparison of mortality at 1 year between the two arms
Time frame: 1 year
Length of hospital stay
comparison of length of hospital stay between the two arms
Time frame: 48months
Kidney function measured by serum creatinine value
Kidney function measured by serum creatinine value
Time frame: D28
Kidney function measured by CKD EPI
Kidney function measured by CKD EPI (= 141 x min(Scr/K,1)a x max(Scr/K,1)-1,209 x 0,993Age x 1,018 (for women)) at Day28
Time frame: D28
Extra renal support requirement defined by percentage of patients requiring at least one dialysis
Extra renal support requirement
Time frame: D28
Kidney graft acute rejection
Kidney graft acute rejection
Time frame: D28
Acute pulmonary oedema by left ventricular failure
Acute pulmonary oedema by left ventricular failure
Time frame: D28
Severe arrythmia
Severe arrythmia will be define by salvo of ventricular extrasystole, ventricular fibrillation, ventricular tachycardia, need an external shock, need anti-arrhythmic treatment.
Time frame: D28
Pulmonary embolism
Pulmonary embolism
Time frame: D28
Acute coronary syndrome
Acute coronary syndrome
Time frame: D28
Nosocomial Bloodstream infection
Nosocomial Bloodstream infection
Time frame: D28
Early onset pneumonia
Early onset pneumonia
Time frame: D28
Central Venous Catheter infection
Central Venous Catheter infection
Time frame: D28
Urinary tract sepsis
Urinary tract sepsis
Time frame: D28
Kidney function measured by serum creatinine value
Kidney function measured by serum creatinine value
Time frame: 3 months
Kidney function measured by CKD EPI
Kidney function measured by CKD EPI (= 141 x min(Scr/K,1)a x max(Scr/K,1)-1,209 x 0,993Age x 1,018 (for women))
Time frame: 3 months
Extra renal support requirement defined by percentage of patients requiring at least one dialysis
Extra renal support requirement
Time frame: 3 months
Kidney function measured by serum creatinine value
Kidney function measured by serum creatinine value
Time frame: 12 months
Kidney function measured by CKD EPI
Kidney function measured by CKD EPI (= 141 x min(Scr/K,1)a x max(Scr/K,1)-1,209 x 0,993Age x 1,018 (for women))
Time frame: 12 months
Extra renal support requirement defined by percentage of patients requiring at least one dialysis
Extra renal support requirement
Time frame: 12 months
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital