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

Heart Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384643
• Other study ID #: 1-2011-0007
• Status: Completed
• Phase: Phase 4
• First received: June 27, 2011
• Last updated: April 10, 2013
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: April 2013
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Valve Disease
• Heart Valve Diseases

Intervention

Drug:
• Propofol
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).

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum creatinine	Comparison of serum creatinine elevation after surgery between Propofol and Control group.	incidence of AKI during 48 hours after the surgery incidence of AKI	No