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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01384643
Enrollment
112
Registered
2011-06-29
Start date
2011-05-31
Completion date
2012-05-31
Last updated
2013-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Disease

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.

Interventions

DRUGPropofol

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).

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Serum creatinineincidence of AKI during 48 hours after the surgery incidence of AKIComparison of serum creatinine elevation after surgery between Propofol and Control group.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026