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Trial record 39 of 657 for:    Sevoflurane

Effects of Preconditioning With Sevoflurane During Organ Procurement From Brain Dead Donors: Impact on Early Function of Liver Allografts

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ClinicalTrials.gov Identifier: NCT02341833
Recruitment Status : Unknown
Verified January 2015 by Gregory Minguet, University of Liege.
Recruitment status was:  Not yet recruiting
First Posted : January 19, 2015
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Gregory Minguet, University of Liege

Brief Summary:
The aim of the investigators study is to investigate the effects of anaesthetic preconditioning with sevoflurane during organs harvesting in brain dead donors. More particularly, the investigators will investigate whether sevoflurane preconditioning protects against ischaemia-reperfusion the livers and kidneys allografts after a prolonged period of cold ischaemia and whether this protection translates in a better clinical functional recovery of these allografts.

Condition or disease Intervention/treatment Phase
Post-transplantation Liver Allograft Function Drug: Sevoflurane Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2015
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arm Intervention/treatment
Active Comparator: Sevoflurane
1 MAC of sevoflurane for 15 minutes before organs procurement.
Drug: Sevoflurane
In the sevoflurane group, the anesthetic agent has to be administered immediately after arrival in the operating room to reach an end-expiratory target concentration of 2%. This concentration of sevoflurane should be maintained until the procedural cardiac arrest and for at least 15 min.

No Intervention: No intervention
No volatile anesthetics during organs procurement



Primary Outcome Measures :
  1. Composite outcome of liver function following liver transplantation. [ Time Frame: First week post-transplantation ]
    • Transaminases, bilirubin, prothrombin time (PT) and international normalized ratio (INR) on the first post-transplantation blood test and on the following samples from the 1st to the 7th postoperative days.
    • Number of liver recipients that will meet the criteria for "early allograft dysfunction" as defined by :

      • bilirubin ≥10 mg/dL on the 7th day.
      • INR ≥ 1.6 on the 7th day.
      • ALAT or ASAT > 2000 UI/L during the first 7 postoperative days.


Secondary Outcome Measures :
  1. • Incidence of primary non function (liver failure requiring emergent re-transplantation) [ Time Frame: 30-day and 6-month after transplantation. ]
  2. • Hospital length of stay. [ Time Frame: 30-day and 6-month after transplantation. ]
  3. • Allograft function (yes/no) at 30-day and 6-month after transplantation. [ Time Frame: 30-day and 6-month after transplantation. ]
  4. • Hospital mortality and at 30-day. [ Time Frame: 30-day. ]

Other Outcome Measures:
  1. Composite outcome of post transplantation kidney function. [ Time Frame: First week after transplantation, 30 day and 6-month. ]
    • Creatinine on the first post-transplantation blood test and on the following samples from the first to the 7th postoperative days. Maximal creatinine values and values at 72-hour after transplantation, the time for 50% decline, and the area under the curve during the first postoperative week.

  2. • Delayed graft function : (defined as dialysis during first postop wk; decline in creatinine value [ Time Frame: First week after transplantation, 30 day and 6-month. ]
    • Dialysis during the first postoperative week.
    • Decline in creatinine value of less than 10% per day during 3 consecutive days.

  3. • Length of delayed graft function. [ Time Frame: First week after transplantation, 30 day and 6-month. ]
  4. • Primary non function (patient who must go back to chronic hemodialysis and must be listed for re-transplantation [ Time Frame: First week after transplantation, 30 day and 6-month. ]
    patient who must go back to chronic hemodialysis and must be listed for re-transplantation, at 30-day and 6-month after transplantation.

  5. • Hospital length of stay. [ Time Frame: First week after transplantation, 30 day and 6-month. ]
  6. • Hospital mortality and mortality at 30-day. [ Time Frame: First week after transplantation, 30 day and 6-month. ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all consecutive brain dead donors in the Belgian university hospitals of Leuven, Brussels, Louvain and Liège eligible for organs harvesting followed by organs transplantation in the Eurotransplant area. There is no age limitation for eligibility

Exclusion Criteria:

  • haemodynamic instability that precludes safe administration of 2% sevoflurane.

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): NCT02341833


Contacts
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Contact: Jean L Joris, MD, PhD 32-4-3667180 jean.joris@chu.ulg.ac.be

Locations
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Belgium
Department of Anesthesiology, CHU Liège Not yet recruiting
Liège, Belgium, B-4000
Contact: Jean L Joris, MD, PhD    32-4-3667180    jean.joris@chu.ulg.ac.be   
Sub-Investigator: Gregory G Minguet, MD         
Sponsors and Collaborators
University of Liege
Investigators
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Principal Investigator: Jean L Joris, MD, PhD University of Liege

Additional Information:
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Responsible Party: Gregory Minguet, Doctor, University of Liege
ClinicalTrials.gov Identifier: NCT02341833     History of Changes
Other Study ID Numbers: 2014-26-06
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Gregory Minguet, University of Liege:
Anesthetic preconditioning
Sevoflurane
Liver transplantation
brain-death donors

Additional relevant MeSH terms:
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Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General