Dexmedetomidine in Pediatric Cardiac Surgery

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Dexmedetomidine; Drug: normal saline

• Registration Number: NCT02888275
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Dexmedetomidine is a selective α-2 receptor agonist with a sedative and cardiopulmonary profile that makes it an attractive anesthetic for pediatric patients with congenital heart disease (CHD). The aim of this study was to investigate the renal protective effect of dexmedetomidine in the perioperative setting in children with heart disease.

Total 144 pediatric patients allocated dexmedetomidine (DEX) and did not receive the drug (NoDEX) group.

The primary objective of this study was to assess the relationship between the use of intraoperative dexmedetomidine and the incidence of acute kidney injury in pediatric patients undergoing cardiopulmonary bypass. The secondary objective was to determine whether there was an association between dexmedetomidine use and duration of mechanical ventilation or cardiovascular ICU stay.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-09-05
• Study Start: 2016-10
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-25
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Patients undergoing congenital cardiac surgery

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Exclusion Criteria

• history of allergy or anaphylaxis to study drug
• preexisting renal dysfunction (preoperative creatinine >1.5mg/dl)
• diabetes
• liver profile abnormality

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEX	Dexmedetomidine	dexmedetomidine 1mcg/kg for 10min. loading and continuous infusion during the surgery 0.5mcg/kg/hr.
no_DEX	normal saline	Normal saline 1mcg/kg for 10min. and continuous infusion during the surgery 0.5mcg/kg/hr.

Primary Outcome Measures

Name	Time	Method
serum creatinine	immediate after surgery, until discharge from the ICU, assessed up to 1 week.	daily check the laboratory parameter.

Secondary Outcome Measures

Name	Time	Method
glomerular filtration rate	immediate after surgery, until discharge from the ICU, assessed up to 1 week.	daily check the laboratory parameter.
Urine output	immediate after surgery, until discharge from the ICU, assessed up to 1 week.	daily check the laboratory parameter.

Trial Locations

Locations (1)

Jin-Tae Kim; 🇰🇷 Seoul, Korea, Republic of