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

Phase 4

Completed

• Conditions: Heart Valve Disease
• Interventions: Drug: Propofol

• Registration Number: NCT01384643
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-06-27
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-29
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-10
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol group	Propofol	-
Control group	Propofol	-

Primary Outcome Measures

Name	Time	Method
Serum creatinine	incidence of AKI during 48 hours after the surgery incidence of AKI	Comparison of serum creatinine elevation after surgery between Propofol and Control group.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of