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Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery

Primary Purpose

Heart Valve Disease

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Propofol

About this trial

This is an interventional prevention trial for Heart Valve Disease

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propofol group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Serum creatinine

Comparison of serum creatinine elevation after surgery between Propofol and Control group.

Secondary Outcome Measures

Full Information

NCT ID

NCT01384643

First Posted

June 27, 2011

Last Updated

April 10, 2013

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT01384643

Brief Title

Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery

Official Title

Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery: A Prospective, Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Valve Disease

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Propofol group

Arm Type

Experimental

Arm Title

Control group

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Propofol

Intervention Description

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).

Primary Outcome Measure Information:

Title

Serum creatinine

Description

Comparison of serum creatinine elevation after surgery between Propofol and Control group.

Time Frame

incidence of AKI during 48 hours after the surgery incidence of AKI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Severance Hospital

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

12. IPD Sharing Statement

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Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery

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