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

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Heart Valve Disease

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01384643

1-2011-0007

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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112 participants in 2 patient groups, including a placebo group

Propofol group

Experimental group

Treatment:

Drug: Propofol

Control group

Placebo Comparator group

Treatment:

Drug: Propofol