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"Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MMRF Struys, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01248871
First received: November 24, 2010
Last updated: December 18, 2012
Last verified: December 2012
History of Changes
  Purpose

To compare the renal protective properties of two currently used anaesthetic techniques - a sevoflurane-remifentanil/sufentanil combination with a propofol-remifentanil/sufentanil combination for anaesthesia in patients undergoing living donor kidney donation/transplantation.


Condition Intervention
Kidney Donation/Transplantation
 Drug: procedure:sevoflurane-remifentanil/sufentanil
Drug: volatile agent only during reperfusion
Drug: propofol-remifentanil/sufentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: "Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • To compare the renal protective properties of two currently used anaesthetic techniques [ Time Frame: participants will be followed for the duration of hospital stay ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: September 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: SEVO
sevoflurane-remifentanil/sufentanil combination
 Drug: procedure:sevoflurane-remifentanil/sufentanil
Active Comparator
Active Comparator: SERE
volatile agent only during reperfusion
 Drug: volatile agent only during reperfusion
Active Comparator
Active Comparator: propofol
propofol-remifentanil/sufentanil
 Drug: propofol-remifentanil/sufentanil
Active Comparator

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients: Age > 18 years

Exclusion Criteria:

  • patient refusal
  • BMI< 17, >35
  • neurological disorder
  • recent use of psycho-active medication, including alcohol.
  • Donor-recipient couples from the ABO-incompatible program
  • Altruistic donor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248871

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 EZ
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: M.M.R.F Struys, Prof.dr. University Medical Centre Groningen
Principal Investigator: R,J. Ploeg, Prof.dr University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: MMRF Struys, Prof.dr., University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01248871     History of Changes
Other Study ID Numbers: VAPOR 001
Study First Received: November 24, 2010
Last Updated: December 18, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Centre Groningen:
renal
transplantation
Volatile
anesthetic

Additional relevant MeSH terms:
Anesthetics
Propofol
Sevoflurane
Remifentanil
Sufentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
 Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013