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NCT01886079 Clinical Trial

The Effects of Dexmedetomidine on Postoperative Renal Function in Valvular Heart Surgery

Acute Kidney Injury Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01886079
Other study ID # 4-2013-0194
Secondary ID
Status Recruiting
Phase Phase 4
First received June 18, 2013
Last updated June 20, 2013
Start date May 2013
Est. completion date May 2015

Study information
Verified date June 2013
Source Yonsei University
Contact Jong Wook Song, MD
Phone 82-2-2228-2420
Email SJW72331@yuhs.ac
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial Summary

The purpose of study is to compare the incidence of acute kidney injury in patients receiving perioperative dexmedetomidine or placebo undergoing valvular heart surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Left ventricular-ejection fraction < 30%

- Preexisting congestive heart failure

- Severe coronary artery disease

- Hemodynamically unstable arrhythmia

- Cardiogenic shock during perioperative period

- Ventricular assist device

- Severe renal dysfunction (eGFR < 15ml/min per 1.73m2)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• dexmedetomidine
0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery
• Saline
0.4 mcg/kg/h, IV

Locations
Country Name City State
Korea, Republic of Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine 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 Comparison of postoperative renal function in patients with or without dexmedetomidine undergoing valvular heart surgery: BUN/Creatinine, cystatin C, eGFR, urine output Incidence of acute kidney injury (based on the AKIN criteria) 24 hours after surgery. No
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