Dexmedetomidine in Pediatric Cardiac Surgery

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888275
• Other study ID #: H1608-052-784
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 2018

Study information

• Verified date: July 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• Dexmedetomidine

• normal saline

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum creatinine	daily check the laboratory parameter.	immediate after surgery, until discharge from the ICU, assessed up to 1 week.
Secondary	glomerular filtration rate	daily check the laboratory parameter.	immediate after surgery, until discharge from the ICU, assessed up to 1 week.
Secondary	Urine output	daily check the laboratory parameter.	immediate after surgery, until discharge from the ICU, assessed up to 1 week.