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Completed

NCT Number: NCT03098706

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

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.

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Key information

Conditions

Organ Donor Body Temperature Changes Brain Death Brain Diseases Central Nervous System Diseases Coma Consciousness Disorders Critical Illness Death Disease Attributes Hypothermia Kidney Transplant; Complications Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens-Picardie, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Normothermia

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.

Other names: Therapeutic hypothermia/ Induce hypothermia

Primary outcomes

  1. rate of patients with delayed graft function (DGF)

    Time frame: 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 outcomes

  1. Temperature Profile

    Time frame: 24 hours

    comparison of temperature profile between the two arms

  2. Severe arrhythmias

    Time frame: 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.

  3. Cardiac arrest

    Time frame: 24 hours

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

  4. Occurrence of hypotension measured by Total dose of inotropic drugs

    Time frame: 24 hours

    Total dose of different inotropic drugs (Epinephrine, Norepinephrine, Dobutamine) will be compare between 2 groups during targetted controlled temperature management period.

  5. Occurrence of hypotension measured by cumulative fluid balance

    Time frame: 24 hours

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

  6. occurrence of cardiac arrest

    Time frame: 24 hours

    comparison of occurrence of cardiac arrest between the two arms

  7. Kidney function measured by serum creatinine value

    Time frame: 24 hours

    Kidney function measured by serum creatinine value

  8. Kidney function measured by CKD EPI score

    Time frame: 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))

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

    Time frame: 24hours

    Potential hypothermia related side effects

  10. glycemia in mmoL/L

    Time frame: 24hours

    Potential hypothermia related side effects

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

    Time frame: 24hours

    Potential hypothermia related side effects

  12. thrombocytopenia in mm3/L

    Time frame: 24hours

    Potential hypothermia related side effects

  13. Number of individual organs transplanted

    Time frame: 24 hours

    Participants will be followed for the duration of Intensive care unit length of stay, and operating room, an average of 24 hours.

  14. Hospital mortality

    Time frame: Day 7

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

  15. Kidney function measured by serum creatinine value

    Time frame: Day 7

    Kidney function measured by serum creatinine value at day7

  16. Kidney function measured by CKD EPI

    Time frame: Day 7

    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))

  17. Extra renal support requirement

    Time frame: Day 7

    Extra renal support requirement at Day7

  18. Kidney graft acute rejection

    Time frame: Day 7

    Kidney graft acute rejection

  19. Acute pulmonary oedema by left ventricular failure

    Time frame: Day 7

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

  20. Severe arrythmia

    Time frame: Day 7

    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

  21. Pulmonary embolism

    Time frame: Day 7

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

  22. Acute coronary syndrome

    Time frame: Day 7

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

  23. Nosocomial Bloodstream infection

    Time frame: Day 7

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

  24. Early onset pneumonia

    Time frame: Day 7

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

  25. Central Venous Catheter infection

    Time frame: Day 7

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

  26. Urinary tract sepsis

    Time frame: Day 7

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

  27. Mortality at D28

    Time frame: D28

    comparison of mortality at D28 between the two arms

  28. Mortality at 3 months

    Time frame: 3 months

    comparison of mortality at 3months between the two arms

  29. Mortality at 1 year

    Time frame: 1 year

    comparison of mortality at 1 year between the two arms

  30. Length of hospital stay

    Time frame: 48months

    comparison of length of hospital stay between the two arms

  31. Kidney function measured by serum creatinine value

    Time frame: D28

    Kidney function measured by serum creatinine value

  32. Kidney function measured by CKD EPI

    Time frame: D28

    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

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

    Time frame: D28

    Extra renal support requirement

  34. Kidney graft acute rejection

    Time frame: D28

    Kidney graft acute rejection

  35. Acute pulmonary oedema by left ventricular failure

    Time frame: D28

    Acute pulmonary oedema by left ventricular failure

  36. Severe arrythmia

    Time frame: D28

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

  37. Pulmonary embolism

    Time frame: D28

    Pulmonary embolism

  38. Acute coronary syndrome

    Time frame: D28

    Acute coronary syndrome

  39. Nosocomial Bloodstream infection

    Time frame: D28

    Nosocomial Bloodstream infection

  40. Early onset pneumonia

    Time frame: D28

    Early onset pneumonia

  41. Central Venous Catheter infection

    Time frame: D28

    Central Venous Catheter infection

  42. Urinary tract sepsis

    Time frame: D28

    Urinary tract sepsis

  43. Kidney function measured by serum creatinine value

    Time frame: 3 months

    Kidney function measured by serum creatinine value

  44. Kidney function measured by CKD EPI

    Time frame: 3 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))

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

    Time frame: 3 months

    Extra renal support requirement

  46. Kidney function measured by serum creatinine value

    Time frame: 12 months

    Kidney function measured by serum creatinine value

  47. Kidney function measured by CKD EPI

    Time frame: 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))

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

    Time frame: 12 months

    Extra renal support requirement

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study 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

Acronym: HYPOREME

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2017
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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