Therapeutic Hypothermia in "Expanded Criteria" Brain-dead Donors and Kidney-graft Function
- Conditions
- HypothermiaCritical IllnessOrgan DonorKidney Transplant; ComplicationsBrain Death
- Interventions
- Procedure: Procedure active
- Registration Number
- NCT03098706
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 532
-
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.
- For transplant recipients : age 18 years or greater /information given and no opposition signed by recipients.
- For donors: no legal determination of death by neurologic criteria/not a deceased organ donor/ medical contre-indication to donation/ no Information given to the authorizing surrogate.
- For transplant recipients: age <18 years / no information given and/or opposition signed by recipients.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HT mild hypothermia Procedure active 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.
- Primary Outcome Measures
Name Time Method rate of patients with delayed graft function (DGF) Day 7 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°).
- Secondary Outcome Measures
Name Time Method Kidney graft acute rejection D28 Kidney graft acute rejection
glycemia in mmoL/L 24hours Potential hypothermia related side effects
Kidney function measured by serum creatinine value 12 months Kidney function measured by serum creatinine value
Acute pulmonary oedema by left ventricular failure D28 Acute pulmonary oedema by left ventricular failure
thrombocytopenia in mm3/L 24hours Potential hypothermia related side effects
Occurrence of hypotension measured by Total dose of inotropic drugs 24 hours Total dose of different inotropic drugs (Epinephrine, Norepinephrine, Dobutamine) will be compare between 2 groups during targetted controlled temperature management period.
Mortality at 3 months 3 months comparison of mortality at 3months between the two arms
Occurrence of hypotension measured by cumulative fluid balance 24 hours Cumulative fluid balance will be compare between 2 groups during targetted controlled temperature management period
Kidney function measured by CKD EPI score 24 hours 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))
Number of individual organs transplanted 24 hours Participants will be followed for the duration of Intensive care unit length of stay, and operating room, an average of 24 hours.
Kidney function measured by CKD EPI 12 months 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))
Nosocomial Bloodstream infection D28 Nosocomial Bloodstream infection
Early onset pneumonia D28 Early onset pneumonia
Urinary tract sepsis D28 Urinary tract sepsis
Mortality at 1 year 1 year comparison of mortality at 1 year between the two arms
Temperature Profile 24 hours comparison of temperature profile between the two arms
Pulmonary embolism D28 Pulmonary embolism
occurrence of cardiac arrest 24 hours comparison of occurrence of cardiac arrest between the two arms
Severe arrhythmias 24 hours 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.
Cardiac arrest 24 hours SParticipants will be followed for the duration of Intensive Care Unit stay and/or operating room, an expected average of 24 hours.
electrolyte balance : potassium, calcium, sodium concentration disorders in mmoL/L 24hours Potential hypothermia related side effects
liver disorder (ASAT, ALAT, GGT, PAL , BILI in UI/L ) 24hours Potential hypothermia related side effects
Hospital mortality Day 7 Participants will be followed for the duration of hospital stay, an expected average of 1 week.
Extra renal support requirement Day 7 Extra renal support requirement at Day7
Severe arrythmia D28 Severe arrythmia will be define by salvo of ventricular extrasystole, ventricular fibrillation, ventricular tachycardia, need an external shock, need anti-arrhythmic treatment.
Mortality at D28 D28 comparison of mortality at D28 between the two arms
Length of hospital stay 48months comparison of length of hospital stay between the two arms
Acute coronary syndrome D28 Acute coronary syndrome
Central Venous Catheter infection D28 Central Venous Catheter infection
Extra renal support requirement defined by percentage of patients requiring at least one dialysis 12 months Extra renal support requirement
Trial Locations
- Locations (54)
Hopital de la Timone
🇫🇷Marseille, France
CH Bourges
🇫🇷Bourges, France
CHU Brest
🇫🇷Brest, France
CHU Caen
🇫🇷Caen, France
CHU Grenoble
🇫🇷Grenoble, France
Ch Cholet
🇫🇷Cholet, France
Hopital de la Conception
🇫🇷Marseille, France
CH de Meaux (GHEF)
🇫🇷Meaux, France
CHU Poitiers
🇫🇷Poitiers, France
CHRU Saint-Etienne
🇫🇷Saint-Étienne, France
CH Marne la Vallée (GHEF)
🇫🇷Jossigny, France
CH Angouleme
🇫🇷Angoulême, France
CHU de Dijon
🇫🇷Dijon, France
CHU de Lyon
🇫🇷Lyon, France
CH Le Mans
🇫🇷Le Mans, France
CHRU Lille
🇫🇷Lille, France
CHU Amiens-Picardie
🇫🇷Amiens, France
CHU d'Angers
🇫🇷Angers, France
CH de Blois
🇫🇷Blois, France
CHU de Bordeaux
🇫🇷Bordeaux, France
CH Avignon
🇫🇷Avignon, France
Chu Clermont Ferrand
🇫🇷Clermont-Ferrand, France
CH Laval
🇫🇷Laval, France
CHU Strasbourg
🇫🇷Strasbourg, France
CH Morlaix
🇫🇷Morlaix, France
CHU Nice
🇫🇷Nice, France
CH Cornouaille
🇫🇷Quimper, France
CH Saint Brieuc
🇫🇷Saint Brieuc, France
CH Saint Nazaire
🇫🇷Saint Nazaire, France
CH Saintes
🇫🇷Saintes, France
CHU Foch
🇫🇷Suresnes, France
Hopital Saint Louis
🇫🇷Paris, France
CHU Tenon
🇫🇷Paris, France
CHRU Nancy
🇫🇷Vandœuvre-lès-Nancy, France
CHU Rouen
🇫🇷Rouen, France
CH Saint Malo
🇫🇷Saint-Malo, France
Hopital de la Pitié Salpetriere
🇫🇷Paris, France
CH de Dreux
🇫🇷Dreux, France
CH La Roche sur Yon
🇫🇷La Roche-sur-Yon, France
Hopital Necker
🇫🇷Paris, France
CH Annecy Genevois
🇫🇷Pringy, France
CHU Reims
🇫🇷Reims, France
CHU Toulouse
🇫🇷Toulouse, France
CH Lorient
🇫🇷Lorient, France
Hopital Henri Mondor
🇫🇷Créteil, France
CH La Rochelle
🇫🇷La Rochelle, France
Hopital Bicetre
🇫🇷Le Kremlin-Bicêtre, France
CHU Limoges
🇫🇷Limoges, France
CHU Montpellier
🇫🇷Montpellier, France
Nantes University Hospital
🇫🇷Nantes, France
CH Orléans
🇫🇷Orléans, France
CHU Rennes
🇫🇷Rennes, France
CHU Tours
🇫🇷Tours, France
CH Vannes
🇫🇷Vannes, France