Dexmedetomidine in Pediatric Cardiac Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02888275

Enrollment

144

Registered

2016-09-05

Start date

2016-10-31

Completion date

2018-08-31

Last updated

2020-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury

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.

Interventions

DRUGDexmedetomidine

DRUGnormal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 6 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026