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

• Sponsor: Yonsei University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01886079
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: dexmedetomidine; Drug: Saline	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Study Start Date: May 1, 2013
• Anticipated Primary Completion Date: May 1, 2015
• Anticipated Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dexmedetomidine group	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
Placebo Comparator: Saline group	Drug: Saline; 0.4 mcg/kg/h, IV

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01886079
• Other Study ID Numbers: 4-2013-0194
• First Posted: Jun 25, 2013
• Last Update Posted: Jun 25, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Acute Kidney Injury; Dexmedetomidine

Study Results

No Results Posted as of Jun 25, 2013