"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:

Drug Information available for: Propofol Sevoflurane Sufentanil citrate Remifentanil hydrochloride

U.S. FDA Resources

Further study details as provided by University Medical Center 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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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


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 Center 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

ClinicalTrials.gov processed this record on September 28, 2016

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