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Organ DonorHYPOREMENCT03098706

Therapeutic Hypothermia in "Expanded Criteria" Brain-dead Donors and Kidney-graft Function

A study testing Procedure active in people with Organ Donor and Brain Death, run by Nantes University Hospital at 54 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Procedure active
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
532 participants
Where
54 sitesFrance
Study dates
8 Nov 2017to 21 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

France54 sites

  • CHU Amiens-Picardie

    Amiens, 80054

  • CHU d'Angers

    Angers, 49000

  • CH Angouleme

    Angoulême, 16959

  • CH Avignon

    Avignon, 84000

  • CH de Blois

    Blois, 41016

  • CHU de Bordeaux

    Bordeaux, 33076

  • CH Bourges

    Bourges, 18020

  • CHU Brest

    Brest, 29200

  • CHU Caen

    Caen, 14000

  • Ch Cholet

    Cholet, 49325

  • Chu Clermont Ferrand

    Clermont-Ferrand

  • Hopital Henri Mondor

    Créteil, 94000

  • CHU de Dijon

    Dijon, 21079

  • CH de Dreux

    Dreux, 28100

  • CHU Grenoble

    Grenoble

  • CH Marne la Vallée (GHEF)

    Jossigny, 77600

  • CH La Roche sur Yon

    La Roche-sur-Yon, 85925

  • CH La Rochelle

    La Rochelle, 17019

  • CH Laval

    Laval, 53000

  • Hopital Bicetre

    Le Kremlin-Bicêtre, 94270

  • CH Le Mans

    Le Mans, 72037

  • CHRU Lille

    Lille, 59000

  • CHU Limoges

    Limoges, 87042

  • CH Lorient

    Lorient, 56322

  • CHU de Lyon

    Lyon

  • Hopital de la Conception

    Marseille, 13005

  • Hopital de la Timone

    Marseille, 13005

  • CH de Meaux (GHEF)

    Meaux

  • CHU Montpellier

    Montpellier

  • CH Morlaix

    Morlaix, 29672

  • Nantes University Hospital

    Nantes, 44093

  • CHU Nice

    Nice, 06000

  • CH Orléans

    Orléans, 45067

  • Hopital Saint Louis

    Paris, 75010

  • Hopital de la Pitié Salpetriere

    Paris, 75013

  • Hopital Necker

    Paris, 75015

  • CHU Tenon

    Paris, 75020

  • CHU Poitiers

    Poitiers, 86000

  • CH Annecy Genevois

    Pringy, 74374

  • CH Cornouaille

    Quimper, 29107

  • CHU Reims

    Reims, 51100

  • CHU Rennes

    Rennes, 35000

  • CHU Rouen

    Rouen, 76000

  • CH Saint Brieuc

    Saint-Brieuc, 22027

  • CHRU Saint-Etienne

    Saint-Etienne, 42055

  • CH Saint Nazaire

    Saint-Nazaire, 44606

  • CH Saintes

    Saintes, 17108

  • CH Saint Malo

    St-Malo, 35403

  • CHU Strasbourg

    Strasbourg, 67091

  • CHU Foch

    Suresnes, 92150

  • CHU Toulouse

    Toulouse, 31403

  • CHU Tours

    Tours, 37044

  • CHRU Nancy

    Vandœuvre-lès-Nancy, 54511

  • CH Vannes

    Vannes, 56000

Other trials in France

About this study

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

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).

Read more

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.

Being tested
Procedure control: normothermia, Procedure active
Medical subject headings
Brain Death, Critical Illness, Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Procedure control: normothermiaProcedure or surgery

    Also called Normothermia

    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.

  • Procedure activeProcedure or surgery

    Also called Therapeutic hypothermia/ Induce hypothermia

    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.

Study groups in NCT03098706
Study groupRoleWhat they receive
NT normothermiaOtherAfter 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.
Receives: Procedure: Procedure control: normothermia
HT mild hypothermiaExperimentalThe 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.
Receives: Procedure: Procedure active

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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°).

    Measured: Day 7

Secondary outcomes (48)

  1. Temperature Profile

    comparison of temperature profile between the two arms

    Measured: 24 hours

  2. 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.

    Measured: 24 hours

  3. Cardiac arrest

    SParticipants will be followed for the duration of Intensive Care Unit stay and/or operating room, an expected average of 24 hours.

    Measured: 24 hours

  4. 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.

    Measured: 24 hours

  5. Occurrence of hypotension measured by cumulative fluid balance

    Cumulative fluid balance will be compare between 2 groups during targetted controlled temperature management period

    Measured: 24 hours

  6. occurrence of cardiac arrest

    comparison of occurrence of cardiac arrest between the two arms

    Measured: 24 hours

  7. Kidney function measured by serum creatinine value

    Kidney function measured by serum creatinine value

    Measured: 24 hours

  8. 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))

    Measured: 24 hours

  9. electrolyte balance : potassium, calcium, sodium concentration disorders in mmoL/L

    Potential hypothermia related side effects

    Measured: 24hours

  10. glycemia in mmoL/L

    Potential hypothermia related side effects

    Measured: 24hours

  11. liver disorder (ASAT, ALAT, GGT, PAL , BILI in UI/L )

    Potential hypothermia related side effects

    Measured: 24hours

  12. thrombocytopenia in mm3/L

    Potential hypothermia related side effects

    Measured: 24hours

  13. 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.

    Measured: 24 hours

  14. Hospital mortality

    Participants will be followed for the duration of hospital stay, an expected average of 1 week.

    Measured: Day 7

  15. Kidney function measured by serum creatinine value

    Kidney function measured by serum creatinine value at day7

    Measured: Day 7

  16. 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))

    Measured: Day 7

  17. Extra renal support requirement

    Extra renal support requirement at Day7

    Measured: Day 7

  18. Kidney graft acute rejection

    Kidney graft acute rejection

    Measured: Day 7

  19. Acute pulmonary oedema by left ventricular failure

    Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days.

    Measured: Day 7

  20. 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

    Measured: Day 7

  21. Pulmonary embolism

    Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days

    Measured: Day 7

  22. Acute coronary syndrome

    Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days

    Measured: Day 7

  23. Nosocomial Bloodstream infection

    Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days

    Measured: Day 7

  24. Early onset pneumonia

    Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days

    Measured: Day 7

  25. Central Venous Catheter infection

    Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days

    Measured: Day 7

  26. Urinary tract sepsis

    Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days

    Measured: Day 7

  27. Mortality at D28

    comparison of mortality at D28 between the two arms

    Measured: D28

  28. Mortality at 3 months

    comparison of mortality at 3months between the two arms

    Measured: 3 months

  29. Mortality at 1 year

    comparison of mortality at 1 year between the two arms

    Measured: 1 year

  30. Length of hospital stay

    comparison of length of hospital stay between the two arms

    Measured: 48months

  31. Kidney function measured by serum creatinine value

    Kidney function measured by serum creatinine value

    Measured: D28

  32. 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

    Measured: D28

  33. Extra renal support requirement defined by percentage of patients requiring at least one dialysis

    Extra renal support requirement

    Measured: D28

  34. Kidney graft acute rejection

    Kidney graft acute rejection

    Measured: D28

  35. Acute pulmonary oedema by left ventricular failure

    Acute pulmonary oedema by left ventricular failure

    Measured: D28

  36. Severe arrythmia

    Severe arrythmia will be define by salvo of ventricular extrasystole, ventricular fibrillation, ventricular tachycardia, need an external shock, need anti-arrhythmic treatment.

    Measured: D28

  37. Pulmonary embolism

    Pulmonary embolism

    Measured: D28

  38. Acute coronary syndrome

    Acute coronary syndrome

    Measured: D28

  39. Nosocomial Bloodstream infection

    Nosocomial Bloodstream infection

    Measured: D28

  40. Early onset pneumonia

    Early onset pneumonia

    Measured: D28

  41. Central Venous Catheter infection

    Central Venous Catheter infection

    Measured: D28

  42. Urinary tract sepsis

    Urinary tract sepsis

    Measured: D28

  43. Kidney function measured by serum creatinine value

    Kidney function measured by serum creatinine value

    Measured: 3 months

  44. 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))

    Measured: 3 months

  45. Extra renal support requirement defined by percentage of patients requiring at least one dialysis

    Extra renal support requirement

    Measured: 3 months

  46. Kidney function measured by serum creatinine value

    Kidney function measured by serum creatinine value

    Measured: 12 months

  47. 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))

    Measured: 12 months

  48. Extra renal support requirement defined by percentage of patients requiring at least one dialysis

    Extra renal support requirement

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2017
  2. Study start8 Nov 2017
  3. Primary completion21 Mar 2022
  4. Study completion21 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03098706
Sponsor's protocol ID
RC16_0041
Acronym
HYPOREME
Status last verified
Jun 2022
First submitted
15 Feb 2017
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38876137

  • 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.

    PubMed 35351701

Questions about this trial

What is this clinical trial studying?

A study testing Procedure active in people with Organ Donor and Brain Death, run by Nantes University Hospital at 54 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of patients with delayed graft function (DGF) (time frame: Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03098706, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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