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NCT Number: NCT01384643

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

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.

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Key information

Conditions

Heart Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Severance Hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Serum creatinine

    Time frame: incidence of AKI during 48 hours after the surgery incidence of AKI

    Comparison of serum creatinine elevation after surgery between Propofol and Control group.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 29, 2011
Registry last updated
Apr 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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