A Comparison of Propofol Based Total Intravenous Anesthesia and Sevoflurane Based Balanced Anesthesia on Renal Protection During Lung Transplantation Under Extracorporeal Membrane Oxygenation - A Prospective, Randomized Trial

August 16, 2016 updated by: Yonsei University
The aim of this study is to investigate whether propofol based total intravenous anesthesia reduces incidence of acute kidney injury following the lung transplantation under extracorporeal membrane oxygenation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University Health System

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sixty adults undergoing lung transplantation under extracorporeal membrane oxygenation

Exclusion Criteria:

  • Patient having propofol allergy, BMI > 30 kg/m2

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol group
Drug: Administration of anesthesia: Propofol
Maintenance of anesthesia with the propofol
Active Comparator: Sevoflurane group
Drug: Administration of anesthesia: Sevoflurane
Maintenance of anesthesia with the sevoflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the incidence of acute kidney injury between the lung transplantation recipients under propofol based anesthesia and inhalation based anesthesia
Time Frame: Postoperative 48 hours
Developement of the acute kidney injury is determined by Plasma neutrophil gelatinase-associated lipocalin (NGAL), Cystatin C, and Creatinine
Postoperative 48 hours

Collaborators and Investigators

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

Sponsor

Yonsei University

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

November 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 8, 2013

First Submitted That Met QC Criteria

December 8, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

August 17, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0648

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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