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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01384643
Other study ID # 1-2011-0007
Secondary ID
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


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
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