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Completed

NCT Number: NCT02888275

Dexmedetomidine in Pediatric Cardiac Surgery

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jin-Tae Kim

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

normal saline

Drug

Primary outcomes

  1. serum creatinine

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

    daily check the laboratory parameter.

Secondary outcomes

  1. glomerular filtration rate

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

    daily check the laboratory parameter.

  2. Urine output

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

    daily check the laboratory parameter.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2016
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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