Dexmedetomidine in Pediatric Cardiac Surgery
The Renal Protective Effect of the Dexmedetomidine in Pediatric Patients Undergoing Cardiac Surgery
1 other identifier
interventional
144
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2016
CompletedFirst Posted
Study publicly available on registry
September 5, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJuly 28, 2020
July 1, 2020
1.8 years
August 30, 2016
July 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
serum creatinine
daily check the laboratory parameter.
immediate after surgery, until discharge from the ICU, assessed up to 1 week.
Secondary Outcomes (2)
glomerular filtration rate
immediate after surgery, until discharge from the ICU, assessed up to 1 week.
Urine output
immediate after surgery, until discharge from the ICU, assessed up to 1 week.
Study Arms (2)
DEX
EXPERIMENTALdexmedetomidine 1mcg/kg for 10min. loading and continuous infusion during the surgery 0.5mcg/kg/hr.
no_DEX
ACTIVE COMPARATORNormal saline 1mcg/kg for 10min. and continuous infusion during the surgery 0.5mcg/kg/hr.
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing congenital cardiac surgery
You may not qualify if:
- history of allergy or anaphylaxis to study drug
- preexisting renal dysfunction (preoperative creatinine \>1.5mg/dl)
- diabetes
- liver profile abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jin-Tae Kim
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
August 30, 2016
First Posted
September 5, 2016
Study Start
October 1, 2016
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
July 28, 2020
Record last verified: 2020-07