Dexmedetomidine on Pediatric Heart Operation

Acute Renal Injury Clinical Trial

Official title:

Renal Effects of Dexmedetomidine During Pediatric Cardiac Surgery: a Randomized Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01920542
• Other study ID #: GCIRB2013-163
• Status: Completed
• Phase: N/A
• First received: August 8, 2013
• Last updated: November 8, 2016
• Start date: September 2013
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients

Description:

dexmedetomidine, a2-adrenoreceptor agonist has been used for sedation or hemodynamic stability for operative procedure. It had been already reported that dexmedetomidine reduce the impairment of renal functon after cardiac operation in adult. we hypothized dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass weaning in pediatric patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

• 1-6yr pediatric cardiac patients

Exclusion Criteria:

• previous renal dysfunction

Study Design

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Injury

Intervention

Drug:
• Dexmedetomidine
administration of dexmedetomidine on dexemedetomidine group
• no dexmedetomidine
no administration of dexmedetomidine on control group

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Cneter	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function	at immediate after anesthetic induction (baseline), after weaning of cardiopulmonary bypass, 2h after end of operationCPB, sodium and creatinine in the urine and serum, N-acetyl-b-glucosaminidase (NAG)and albumin in only urine could be studied	from anesthetic induction up to postoperative 2h	Yes