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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Impact of Therapeutic Hypothermia in Expanded Criteria Brain-dead Donors on Kidney-graft Function in the Kidney-transplant Recipients: Multicenter Randomized Controlled Tr

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.


Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: 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°).



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Temperature Profile [ Time Frame: 24 hours ]
    comparison of temperature profile between the two arms
  • 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.
  • 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.
  • 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.
  • 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
  • occurrence of cardiac arrest [ Time Frame: 24 hours ]
    comparison of occurrence of cardiac arrest between the two arms
  • Kidney function measured by serum creatinine value [ Time Frame: 24 hours ]
    Kidney function measured by serum creatinine value
  • 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))
  • electrolyte balance : potassium, calcium, sodium concentration disorders in mmoL/L [ Time Frame: 24hours ]
    Potential hypothermia related side effects
  • glycemia in mmoL/L [ Time Frame: 24hours ]
    Potential hypothermia related side effects
  • liver disorder (ASAT, ALAT, GGT, PAL , BILI in UI/L ) [ Time Frame: 24hours ]
    Potential hypothermia related side effects
  • thrombocytopenia in mm3/L [ Time Frame: 24hours ]
    Potential hypothermia related side effects
  • 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.
  • Hospital mortality [ Time Frame: Day 7 ]
    Participants will be followed for the duration of hospital stay, an expected average of 1 week.
  • Kidney function measured by serum creatinine value [ Time Frame: Day 7 ]
    Kidney function measured by serum creatinine value at day7
  • 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))
  • Extra renal support requirement [ Time Frame: Day 7 ]
    Extra renal support requirement at Day7
  • Kidney graft acute rejection [ Time Frame: Day 7 ]
    Kidney graft acute rejection
  • 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.
  • 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

  • Pulmonary embolism [ Time Frame: Day 7 ]
    Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days
  • Acute coronary syndrome [ Time Frame: Day 7 ]
    Participants will be followed for the duration of transplantation unit stay, an expected average

    Original Secondary Outcome:

    • Temperature Profile [ Time Frame: 24 hours ]
      comparison of temperature profile between the two arms
    • 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.
    • 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.
    • 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.
    • 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
    • occurrence of cardiac arrest [ Time Frame: 24 hours ]
      comparison of occurrence of cardiac arrest between the two arms
    • Kidney function measured by serum creatinine value [ Time Frame: 24 hours ]
      Kidney function measured by serum creatinine value
    • 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))
    • electrolyte balance : potassium, calcium, sodium concentration disorders in mmoL/L [ Time Frame: 24hours ]
      Potential hypothermia related side effects
    • glycemia in mmoL/L [ Time Frame: 24hours ]
      Potential hypothermia related side effects
    • liver disorder (ASAT, ALAT, GGT, PAL , BILI in UI/L ) [ Time Frame: 24hours ]
      Potential hypothermia related side effects
    • thrombocytopenia in mm3/L [ Time Frame: 24hours ]
      Potential hypothermia related side effects
    • 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.
    • Hospital mortality [ Time Frame: Day 7 ]
      Participants will be followed for the duration of hospital stay, an expected average of 1 week.
    • Kidney function measured by serum creatinine value [ Time Frame: Day 7 ]
      Kidney function measured by serum creatinine value at day7
    • 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))
    • Extra renal support requirement [ Time Frame: Day 7 ]
      Extra renal support requirement at Day7
    • Kidney graft acute rejection [ Time Frame: Day 7 ]
      Kidney graft acute rejection
    • 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.
    • 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

    • Pulmonary embolism [ Time Frame: Day 7 ]
      Participants will be followed for the duration of transplantation unit stay, an expected average of 7 days
    • Acute coronary syndrome [ Time Frame: Day 7 ]
      Participants will be followed for the duration of transplantation unit stay, an expected average

      Information By: Nantes University Hospital

      Dates:
      Date Received: February 15, 2017
      Date Started: May 1, 2017
      Date Completion: May 1, 2021
      Last Updated: April 6, 2017
      Last Verified: April 2017