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

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ClinicalTrials.gov Identifier: NCT01248871
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):
MMRF Struys, University Medical Centre Groningen

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Donation/Transplantation Drug: procedure:sevoflurane-remifentanil/sufentanil Drug: volatile agent only during reperfusion Drug: propofol-remifentanil/sufentanil Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: "Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail
Study Start Date : September 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. To compare the renal protective properties of two currently used anaesthetic techniques [ Time Frame: participants will be followed for the duration of hospital stay ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01248871


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713 EZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: M.M.R.F Struys, Prof.dr. University Medical Center Groningen
Principal Investigator: R,J. Ploeg, Prof.dr University Medical Center Groningen
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MMRF Struys, Prof.dr., University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01248871     History of Changes
Other Study ID Numbers: VAPOR 001
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

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

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