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Trial record 42 of 107 for:    Recruiting, Not yet recruiting, Available Studies | "Hypothermia"

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

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ClinicalTrials.gov Identifier: NCT03098706
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Organ Donor Brain Death Procedure: Procedure control: normothermia Procedure: Procedure active Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 516 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
NT normothermia
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.
Procedure: Procedure control: 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.
Other Name: Normothermia

Experimental: HT mild hypothermia
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.
Procedure: Procedure active
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 Name: Therapeutic hypothermia/ Induce hypothermia




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098706


Contacts
Contact: Noelle BRULE, MD 33 (0)2 40 08 73 62 noelle.brule@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Noëlle Brulé, Dr       noelle.brule@chu-nantes.fr   
Principal Investigator: Noëlle Brulé, Dr         
Sponsors and Collaborators
Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03098706     History of Changes
Other Study ID Numbers: RC16_0041
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypothermia
Brain Death
Body Temperature Changes
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Pathologic Processes