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

April 16, 2024 updated by: University Medical Center Groningen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 EZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the renal protective properties of two currently used anaesthetic techniques
Time Frame: participants will be followed for the duration of hospital stay
participants will be followed for the duration of hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimated)

November 25, 2010

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAPOR 001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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