Clinical trial NCT03098706: Therapeutic Hypothermia in "Expanded Criteria" Brain-dead Donors and Kidney-graft Function
Official title: Impact of Therapeutic Hypothermia in Expanded Criteria Brain-dead Donors on Kidney-graft Function in the Kidney-transplant Recipients: Multicenter Randomized Controlled Trial" HYPOREME
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Donor
Brain Death
Kidney Transplant; Complications
Critical Illness
Hypothermia
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2017-04-04
Enrollment: 532
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: rate of patients with delayed graft function (DGF)
timeFrame: Day 7
Secondary outcomes:
measure: Temperature Profile
timeFrame: 24 hours
measure: Severe arrhythmias
timeFrame: 24 hours
measure: Cardiac arrest
timeFrame: 24 hours
measure: Occurrence of hypotension measured by Total dose of inotropic drugs
timeFrame: 24 hours
measure: Occurrence of hypotension measured by cumulative fluid balance
timeFrame: 24 hours
measure: occurrence of cardiac arrest
timeFrame: 24 hours
measure: Kidney function measured by serum creatinine value
timeFrame: 24 hours
measure: Kidney function measured by CKD EPI score
timeFrame: 24 hours
measure: electrolyte balance : potassium, calcium, sodium concentration disorders in mmoL/L
timeFrame: 24hours
measure: glycemia in mmoL/L
timeFrame: 24hours
measure: liver disorder (ASAT, ALAT, GGT, PAL , BILI in UI/L )
timeFrame: 24hours
measure: thrombocytopenia in mm3/L
timeFrame: 24hours
measure: Number of individual organs transplanted
timeFrame: 24 hours
measure: Hospital mortality
timeFrame: Day 7
measure: Kidney function measured by serum creatinine value
timeFrame: Day 7
measure: Kidney function measured by CKD EPI
timeFrame: Day 7
measure: Extra renal support requirement
timeFrame: Day 7
measure: Kidney graft acute rejection
timeFrame: Day 7
measure: Acute pulmonary oedema by left ventricular failure
timeFrame: Day 7
measure: Severe arrythmia
timeFrame: Day 7
measure: Pulmonary embolism
timeFrame: Day 7
measure: Acute coronary syndrome
timeFrame: Day 7
measure: Nosocomial Bloodstream infection
timeFrame: Day 7
measure: Early onset pneumonia
timeFrame: Day 7
measure: Central Venous Catheter infection
timeFrame: Day 7
measure: Urinary tract sepsis
timeFrame: Day 7
measure: Mortality at D28
timeFrame: D28
measure: Mortality at 3 months
timeFrame: 3 months
measure: Mortality at 1 year
timeFrame: 1 year
measure: Length of hospital stay
timeFrame: 48months
measure: Kidney function measured by serum creatinine value
timeFrame: D28
measure: Kidney function measured by CKD EPI
timeFrame: D28
measure: Extra renal support requirement defined by percentage of patients requiring at least one dialysis
timeFrame: D28
measure: Kidney graft acute rejection
timeFrame: D28
measure: Acute pulmonary oedema by left ventricular failure
timeFrame: D28
measure: Severe arrythmia
timeFrame: D28
measure: Pulmonary embolism
timeFrame: D28
measure: Acute coronary syndrome
timeFrame: D28
measure: Nosocomial Bloodstream infection
timeFrame: D28
measure: Early onset pneumonia
timeFrame: D28
measure: Central Venous Catheter infection
timeFrame: D28
measure: Urinary tract sepsis
timeFrame: D28
measure: Kidney function measured by serum creatinine value
timeFrame: 3 months
measure: Kidney function measured by CKD EPI
timeFrame: 3 months
measure: Extra renal support requirement defined by percentage of patients requiring at least one dialysis
timeFrame: 3 months
measure: Kidney function measured by serum creatinine value
timeFrame: 12 months
measure: Kidney function measured by CKD EPI
timeFrame: 12 months
measure: Extra renal support requirement defined by percentage of patients requiring at least one dialysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
city: Angers
country: France
facility: CHU d'Angers
city: Angoulême
country: France
facility: CH Angouleme
city: Avignon
country: France
facility: CH Avignon
city: Blois
country: France
facility: CH de Blois
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Bourges
country: France
facility: CH Bourges
city: Brest
country: France
facility: CHU Brest
city: Caen
country: France
facility: CHU Caen
city: Cholet
country: France
facility: Ch Cholet
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: Dreux
country: France
facility: CH de Dreux
city: Grenoble
country: France
facility: CHU Grenoble
city: Jossigny
country: France
facility: CH Marne la Vallée (GHEF)
city: La Roche-sur-Yon
country: France
facility: CH La Roche sur Yon
city: La Rochelle
country: France
facility: CH La Rochelle
city: Laval
country: France
facility: CH Laval
city: Le Kremlin-Bicêtre
country: France
facility: Hopital Bicetre
city: Le Mans
country: France
facility: CH Le Mans
city: Lille
country: France
facility: CHRU Lille
city: Limoges
country: France
facility: CHU Limoges
city: Lorient
country: France
facility: CH Lorient
city: Lyon
country: France
facility: CHU de Lyon
city: Marseille
country: France
facility: Hopital de la Conception
city: Marseille
country: France
facility: Hopital de la Timone
city: Meaux
country: France
facility: CH de Meaux (GHEF)
city: Montpellier
country: France
facility: CHU Montpellier
city: Morlaix
country: France
facility: CH Morlaix
city: Nantes
country: France
facility: Nantes University Hospital
city: Nice
country: France
facility: CHU Nice
city: Orléans
country: France
facility: CH Orléans
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital de la Pitié Salpetriere
city: Paris
country: France
facility: Hopital Necker
city: Paris
country: France
facility: CHU Tenon
city: Poitiers
country: France
facility: CHU Poitiers
city: Pringy
country: France
facility: CH Annecy Genevois
city: Quimper
country: France
facility: CH Cornouaille
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: CHU Rennes
city: Rouen
country: France
facility: CHU Rouen
city: Saint Brieuc
country: France
facility: CH Saint Brieuc
city: Saint Nazaire
country: France
facility: CH Saint Nazaire
city: Saint-Malo
country: France
facility: CH Saint Malo
city: Saint-Étienne
country: France
facility: CHRU Saint-Etienne
city: Saintes
country: France
facility: CH Saintes
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Suresnes
country: France
facility: CHU Foch
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Tours
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy
city: Vannes
country: France
facility: CH Vannes
Study officials:
References:
citation: Brule N, Canet E, Pere M, Feuillet F, Hourmant M, Asehnoune K, Rozec B, Duveau A, Dube L, Pierrot M, Humbert S, Tirot P, Boyer JM, Martin-Lefevre L, Labadie F, Robert R, Benard T, Kerforne T, Thierry A, Lesieur O, Vincent JF, Lesouhaitier M, Larmet R, Vigneau C, Goepp A, Bouju P, Quentin C, Egreteau PY, Huet O, Renault A, Le Meur Y, Venhard JC, Buchler M, Michel O, Voellmy MH, Herve F, Schnell D, Courte A, Glotz D, Amrouche L, Hazzan M, Kamar N, Moal V, Bourenne J, Le Quintrec-Donnette M, Morelon E, Boulain T, Grimbert P, Heng AE, Merville P, Garin A, Hiesse C, Fermier B, Mousson C, Guyot-Colosio C, Bouvier N, Rerolle JP, Durrbach A, Drouin S, Caillard S, Frimat L, Girerd S, Albano L, Rostaing L, Bertrand D, Hertig A, Westeel PF, Montini F, Delpierre E, Dorez D, Alamartine E, Ouisse C, Sebille V, Reignier J. Impact of targeted hypothermia in expanded-criteria organ donors on recipient kidney-graft function: study protocol for a multicentre randomised controlled trial (HYPOREME). BMJ Open. 2022 Mar 28;12(3):e052845. doi: 10.1136/bmjopen-2021-052845.