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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Acute Kidney Injury

Treatments: Drug: Saline; Drug: dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01886079

4-2013-0194

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Dexmedetomidine group

Experimental group

Treatment:

Drug: dexmedetomidine

Saline group

Placebo Comparator group

Treatment:

Drug: Saline