- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01384643
Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery
April 10, 2013 updated by: Yonsei University
Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery: A Prospective, Randomized Controlled Trial
Ischemia/reperfusion (I/R)-induced acute kidney injury is a serious complication affecting patient outcome following cardiovascular surgeries.
Propofol, an intravenously administered anesthetic with antioxidant properties, protects organs from I/R injury.
This study aimed to investigate the ability of propofol to protect kidneys against I/R injury in the patients undergoing valvular heart surgery.
Study Overview
Study Type
Interventional
Enrollment (Actual)
112
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
-
-
-
Seoul, Korea, Republic of, 120-752
- Severance Hospital
-
-
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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing valvular heart surgery.
- Age: 20~75.
Exclusion Criteria:
- Emergency operation.
- Patients with vitamin E or vitamin C within 5 days before surgery.
- Patients with preoperative C-reactive protein (CRP) > 16 mg/L.
- Patients with serum creatinine ≥ 2.0 mg/dL
- Patients under hemodialysis.
- Patients with acute myocardial infarction within 1 week before surgery
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control group
|
Induction of anesthesia: Propofol 1 mg/kg, sufentanil 1.0-3.0
µg/kg and rocuronium 50 mg IV Maintenance of anesthesia (pre CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3
µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Maintenance of anesthesia (during CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 IV infusion Weaning from CPB: Sufentanil 50 µg IV Maintenance of anesthesia (post CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3
µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Propofol infusion rate is titrated using bispectral index (40-60).
|
Experimental: Propofol group
|
Induction of anesthesia: Propofol 1 mg/kg, sufentanil 1.0-3.0
µg/kg and rocuronium 50 mg IV Maintenance of anesthesia (pre CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3
µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Maintenance of anesthesia (during CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 IV infusion Weaning from CPB: Sufentanil 50 µg IV Maintenance of anesthesia (post CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3
µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Propofol infusion rate is titrated using bispectral index (40-60).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum creatinine
Time Frame: incidence of AKI during 48 hours after the surgery incidence of AKI
|
Comparison of serum creatinine elevation after surgery between Propofol and Control group.
|
incidence of AKI during 48 hours after the surgery incidence of AKI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
June 27, 2011
First Submitted That Met QC Criteria
June 27, 2011
First Posted (Estimate)
June 29, 2011
Study Record Updates
Last Update Posted (Estimate)
April 12, 2013
Last Update Submitted That Met QC Criteria
April 10, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2011-0007
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.
Clinical Trials on Heart Valve Disease
-
Caisson Interventional LLCActive, not recruitingMitral Regurgitation | Valve Disease, Heart | Valve Heart Disease | Mitral Valve Disease | Mitral Valve Failure | Mitral DiseaseUnited States
-
Universitätsklinikum Hamburg-EppendorfRecruitingAortic Valve Disease | Heart Valve Diseases | Mitral Valve Disease | Tricuspid Valve DiseaseGermany
-
InnovHeartActive, not recruitingHeart Valve Diseases | Mitral Regurgitation | Valve Heart Disease | Mitral Valve Disease | Mitral DiseaseLithuania, Denmark, Hungary
-
Assistance Publique Hopitaux De MarseilleSuspendedAortic Valve Regurgitation AcquiredFrance
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingAortic Valve Disease | Cardiac Valve Disease | Mitral Valve Disease | Tricuspid Valve DiseaseNetherlands
-
Azienda Ospedaliero-Universitaria CareggiRecruitingAortic Valve Stenosis | Aortic Valve Insufficiency | Valvular Heart Disease | Tricuspid Regurgitation | Mitral Valve DiseaseItaly
-
Closed Joint-Stock Company NeoCorResearch Institute for Complex Problems of Cardiovascular Diseases, Russia; CT Medical Limited Liability CompanyRecruitingAortic Valve Disease | Mitral Valve DiseaseRussian Federation
-
Edwards LifesciencesWithdrawnCardiovascular Disease | Heart Disease | Heart Valve Disease | Mitral Insufficiency
-
Ziekenhuis Oost-LimburgUniversitaire Ziekenhuizen KU LeuvenRecruiting
-
Edwards LifesciencesTerminatedCardiovascular Disease | Heart Disease | Heart Valve Disease | Mitral InsufficiencyNetherlands, United Kingdom, Denmark, France
Clinical Trials on Propofol
-
Hopital FochCompleted
-
Konkuk University Medical CenterCompletedCoronary Artery Disease | Valvular Heart DiseaseKorea, Republic of
-
University Medical Center GroningenCompletedAnesthesia | Hemodynamic Instability | Interaction | Disorder of Oxygen TransportNetherlands
-
Asan Medical CenterCompletedPopulation Pharmacokinetics/Pharmacodynamics (PK/PD) of Microemulsion Propofol in Healthy VolunteersHealthyKorea, Republic of
-
Tiva GroupMedtronic - MITGCompleted
-
Pontificia Universidad Catolica de ChileCompletedSurgery | Anesthesia | Depth of Anesthesia | NeonateChile
-
Mansoura UniversityCompleted
-
KVG Medical College and HospitalUnknown
-
Acibadem UniversityCompleted