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

NCT01384643 | Completed Phase 4

• 1 other identifier: 1-2011-0007
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Valve Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Propofol group

EXPERIMENTAL

Drug: Propofol

Control group

PLACEBO COMPARATOR

Drug: Propofol

Interventions

Propofol DRUG

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).

Control group; Propofol group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing valvular heart surgery.
• Age: 20\~75.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Propofol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 29, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 12, 2013

Record last verified: 2013-04

Locations

KR (1)