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Dexmedetomidine in Pediatric Cardiac Surgery

Primary Purpose

Acute Kidney Injury

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Dexmedetomidine

normal saline

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

undefined - 6 Years (Child)All SexesDoes not accept 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

Sites / Locations

Jin-Tae Kim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DEX

no_DEX

Arm Description

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

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

Outcomes

Primary Outcome Measures

serum creatinine

daily check the laboratory parameter.

Secondary Outcome Measures

glomerular filtration rate

daily check the laboratory parameter.

Urine output

daily check the laboratory parameter.

Full Information

NCT ID

NCT02888275

First Posted

August 30, 2016

Last Updated

July 25, 2020

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02888275

Brief Title

Dexmedetomidine in Pediatric Cardiac Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

October 2016 (Actual)

Primary Completion Date

August 2018 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DEX

Arm Type

Experimental

Arm Description

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

Arm Title

no_DEX

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Intervention Type

Drug

Intervention Name(s)

normal saline

Primary Outcome Measure Information:

Title

serum creatinine

Description

daily check the laboratory parameter.

Time Frame

immediate after surgery, until discharge from the ICU, assessed up to 1 week.

Secondary Outcome Measure Information:

Title

glomerular filtration rate

Description

daily check the laboratory parameter.

Time Frame

immediate after surgery, until discharge from the ICU, assessed up to 1 week.

Title

Urine output

Description

daily check the laboratory parameter.

Time Frame

immediate after surgery, until discharge from the ICU, assessed up to 1 week.

10. Eligibility

Sex

All

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Jin-Tae Kim

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

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Dexmedetomidine in Pediatric Cardiac Surgery

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