Dexmedetomidine in Pediatric Cardiac Surgery

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02888275

Collaborator

(none)

144

Enrollment

Location

Arms

Actual Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: Dexmedetomidine Drug: normal saline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

144 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

The Renal Protective Effect of the Dexmedetomidine in Pediatric Patients Undergoing Cardiac Surgery

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DEX dexmedetomidine 1mcg/kg for 10min. loading and continuous infusion during the surgery 0.5mcg/kg/hr.	Drug: Dexmedetomidine
Active Comparator: no_DEX Normal saline 1mcg/kg for 10min. and continuous infusion during the surgery 0.5mcg/kg/hr.	Drug: normal saline

Arm

Intervention/Treatment

Experimental: DEX

dexmedetomidine 1mcg/kg for 10min. loading and continuous infusion during the surgery 0.5mcg/kg/hr.

Drug: Dexmedetomidine

Active Comparator: no_DEX

Normal saline 1mcg/kg for 10min. and continuous infusion during the surgery 0.5mcg/kg/hr.

Drug: normal saline

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing congenital cardiac surgery

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jin-Tae Kim	Seoul		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin-Tae Kim, professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT02888275

Other Study ID Numbers:

H1608-052-784

First Posted:

Sep 5, 2016

Last Update Posted:

Jul 28, 2020

Last Verified:

Jul 1, 2020

Additional relevant MeSH terms:

Acute Kidney Injury

Dexmedetomidine

Study Results

No Results Posted as of Jul 28, 2020