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

Phase 4

• Conditions: Acute Kidney Injury
• Interventions: Drug: Saline; Drug: dexmedetomidine

• Registration Number: NCT01886079
• Lead Sponsor: Yonsei University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Status Verified: 2013-06
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-20
• Last Update Submitted: 2013-06-20
• Study First Posted: 2013-06-25
• Last Update Posted: 2013-06-25
• Primary Completion: 2015-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline group	Saline	-
Dexmedetomidine group	dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
Comparison of postoperative renal function in patients with or without dexmedetomidine undergoing valvular heart surgery:	24 hours after surgery.	BUN/Creatinine, cystatin C, eGFR, urine output Incidence of acute kidney injury (based on the AKIN criteria)

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of