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The Effects of Statin on Postoperative Renal Function in Valvular Heart Surgery: a Randomized, Placebo-controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01909739
Enrollment
200
Registered
2013-07-26
Start date
2013-07-31
Completion date
2015-08-21
Last updated
2019-03-28

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

Conditions

Acute Kidney Injury

Keywords

AKI, atrovastatin, Valvular heart surgery

Brief summary

The aim of this study is to examine the association between preoperative statin treatment and the incidence of postoperative acute kidney injury(AKI) in patients undergoing valvular heart surgery.

Interventions

Atrovastatin 80mg was administered orally on the evening before surgery. Before anesthesia induction, atrovastatin 40mg was administered orally. And atrovastatin 40mg were administered orally in the evening of postoperative days 0, 1, and 2.

DRUGPlacebo

Placebo 80mg was administered orally on the evening before surgery. Before anesthesia induction, placebo 40mg was administered orally. And placebo 40mg were administered orally in the evening of postoperative days 0, 1, and 2.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

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

Eligibility

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

Inclusion criteria

\- patients over the age of 20 scheduled for valvular heart surgery

Exclusion criteria

1. Current statin use 2. Left ventricular ejection fraction \< 30% 3. Preexisting congestive heart failure 4. Severe coronary artery disease 5. Hemodynamically unstable arrhythmia 6. Cardiogenic shock during perioperative period 7. Ventricular assist device 8. Severe renal dysfunction (eGFR \< 15 ml/min per 1.73 m2) 9. History of liver disease or elevated serum transaminases 10. History of rhabdomyolysis or elevated creatinine kinase

Design outcomes

Primary

MeasureTime frameDescription
Comparison of postoperative renal function with or without statin in patients undergoing valvular heart surgeryrenal function change from 24-hour after surgery to 120-hour after sureryBUN/Cr cystatin C eGFR urine output incidence of acute kidney injury(based on the AKIN criteria)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026