Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NT normothermia | Other | 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. |
|
| HT mild hypothermia | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure control: normothermia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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°). | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Temperature Profile | comparison of temperature profile between the two arms | 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. |
Not provided
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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens-Picardie | Amiens | 80054 | France | |||
| CHU d'Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38876137 | Derived | HYPOREME Trial Group. Hypothermia for expanded criteria organ donors in kidney transplantation in France (HYPOREME): a multicentre, randomised controlled trial. Lancet Respir Med. 2024 Sep;12(9):693-702. doi: 10.1016/S2213-2600(24)00117-6. Epub 2024 Jun 11. | |
| 35351701 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Procedure active | Procedure | 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. |
|
|
| 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. | 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. | 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 | 24 hours |
| occurrence of cardiac arrest | comparison of occurrence of cardiac arrest between the two arms | 24 hours |
| Kidney function measured by serum creatinine value | Kidney function measured by serum creatinine value | 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)) | 24 hours |
| electrolyte balance : potassium, calcium, sodium concentration disorders in mmoL/L | Potential hypothermia related side effects | 24hours |
| glycemia in mmoL/L | Potential hypothermia related side effects | 24hours |
| liver disorder (ASAT, ALAT, GGT, PAL , BILI in UI/L ) | Potential hypothermia related side effects | 24hours |
| thrombocytopenia in mm3/L | Potential hypothermia related side effects | 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. | 24 hours |
| Hospital mortality | Participants will be followed for the duration of hospital stay, an expected average of 1 week. | Day 7 |
| Kidney function measured by serum creatinine value | Kidney function measured by serum creatinine value at day7 | 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)) | Day 7 |
| Extra renal support requirement | Extra renal support requirement at Day7 | Day 7 |
| Kidney graft acute rejection | Kidney graft acute rejection | 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. | 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 | Day 7 |
| Pulmonary embolism | Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days | Day 7 |
| Acute coronary syndrome | Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days | Day 7 |
| Nosocomial Bloodstream infection | Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days | Day 7 |
| Early onset pneumonia | Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days | Day 7 |
| Central Venous Catheter infection | Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days | Day 7 |
| Urinary tract sepsis | Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days | Day 7 |
| Mortality at D28 | comparison of mortality at D28 between the two arms | D28 |
| Mortality at 3 months | comparison of mortality at 3months between the two arms | 3 months |
| Mortality at 1 year | comparison of mortality at 1 year between the two arms | 1 year |
| Length of hospital stay | comparison of length of hospital stay between the two arms | 48months |
| Kidney function measured by serum creatinine value | Kidney function measured by serum creatinine value | 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 | D28 |
| Extra renal support requirement defined by percentage of patients requiring at least one dialysis | Extra renal support requirement | D28 |
| Kidney graft acute rejection | Kidney graft acute rejection | D28 |
| Acute pulmonary oedema by left ventricular failure | Acute pulmonary oedema by left ventricular failure | 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. | D28 |
| Pulmonary embolism | Pulmonary embolism | D28 |
| Acute coronary syndrome | Acute coronary syndrome | D28 |
| Nosocomial Bloodstream infection | Nosocomial Bloodstream infection | D28 |
| Early onset pneumonia | Early onset pneumonia | D28 |
| Central Venous Catheter infection | Central Venous Catheter infection | D28 |
| Urinary tract sepsis | Urinary tract sepsis | D28 |
| Kidney function measured by serum creatinine value | Kidney function measured by serum creatinine value | 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)) | 3 months |
| Extra renal support requirement defined by percentage of patients requiring at least one dialysis | Extra renal support requirement | 3 months |
| Kidney function measured by serum creatinine value | Kidney function measured by serum creatinine value | 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)) | 12 months |
| Extra renal support requirement defined by percentage of patients requiring at least one dialysis | Extra renal support requirement | 12 months |
| Angers |
| 49000 |
| France |
| CH Angouleme | Angoulême | 16959 | France |
| CH Avignon | Avignon | 84000 | France |
| CH de Blois | Blois | 41016 | France |
| CHU de Bordeaux | Bordeaux | 33076 | France |
| CH Bourges | Bourges | 18020 | France |
| CHU Brest | Brest | 29200 | France |
| CHU Caen | Caen | 14000 | France |
| Ch Cholet | Cholet | 49325 | France |
| Chu Clermont Ferrand | Clermont-Ferrand | France |
| Hopital Henri Mondor | Créteil | 94000 | France |
| CHU de Dijon | Dijon | 21079 | France |
| CH de Dreux | Dreux | 28100 | France |
| CHU Grenoble | Grenoble | France |
| CH Marne la Vallée (GHEF) | Jossigny | 77600 | France |
| CH La Roche sur Yon | La Roche-sur-Yon | 85925 | France |
| CH La Rochelle | La Rochelle | 17019 | France |
| CH Laval | Laval | 53000 | France |
| Hopital Bicetre | Le Kremlin-Bicêtre | 94270 | France |
| CH Le Mans | Le Mans | 72037 | France |
| CHRU Lille | Lille | 59000 | France |
| CHU Limoges | Limoges | 87042 | France |
| CH Lorient | Lorient | 56322 | France |
| CHU de Lyon | Lyon | France |
| Hopital de la Conception | Marseille | 13005 | France |
| Hopital de la Timone | Marseille | 13005 | France |
| CH de Meaux (GHEF) | Meaux | France |
| CHU Montpellier | Montpellier | France |
| CH Morlaix | Morlaix | 29672 | France |
| Nantes University Hospital | Nantes | 44093 | France |
| CHU Nice | Nice | 06000 | France |
| CH Orléans | Orléans | 45067 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Hopital de la Pitié Salpetriere | Paris | 75013 | France |
| Hopital Necker | Paris | 75015 | France |
| CHU Tenon | Paris | 75020 | France |
| CHU Poitiers | Poitiers | 86000 | France |
| CH Annecy Genevois | Pringy | 74374 | France |
| CH Cornouaille | Quimper | 29107 | France |
| CHU Reims | Reims | 51100 | France |
| CHU Rennes | Rennes | 35000 | France |
| CHU Rouen | Rouen | 76000 | France |
| CH Saint Brieuc | Saint-Brieuc | 22027 | France |
| CHRU Saint-Etienne | Saint-Etienne | 42055 | France |
| CH Saint Nazaire | Saint-Nazaire | 44606 | France |
| CH Saintes | Saintes | 17108 | France |
| CH Saint Malo | St-Malo | 35403 | France |
| CHU Strasbourg | Strasbourg | 67091 | France |
| CHU Foch | Suresnes | 92150 | France |
| CHU Toulouse | Toulouse | 31403 | France |
| CHU Tours | Tours | 37044 | France |
| CHRU Nancy | Vandœuvre-lès-Nancy | 54511 | France |
| CH Vannes | Vannes | 56000 | France |
| ID | Term |
|---|---|
| D001926 | Brain Death |
| D016638 | Critical Illness |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
Not provided
Not provided