Status:

NOT_YET_RECRUITING

DEX vs SEVO in Congenital Heart Surgery

Lead Sponsor:

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Conditions:

Heart Defects, Congenital

Eligibility:

All Genders

1-3 years

Phase:

PHASE4

Brief Summary

Anesthesia-related neurotoxicity in the developing brain is still a concern although evidence in humans is debatable. Moreover, it is unclear whether repeated and/or prolonged exposures are harmless a...

Eligibility Criteria

Inclusion

  • Patients up to 3 years
  • Must undergo cardiac surgery with CPB

Exclusion

  • Preoperative chronic kidney disease (glomerular filtration rate of less than 30 ml/min per 1.73m2 for greater than 3 months)
  • Preoperative cerebral hemorrhage, stroke or
  • Preoperative seizures
  • Abnormal preoperative cerebral ultrasound
  • Preoperative Extracorporeal Life Support
  • Preoperative sedated and intubated patients
  • Preterm newborns (\< 32 W gestational age)
  • Newborns weighing \< 2 kg
  • Patients with Williams-Beuren syndrome.

Key Trial Info

Start Date :

January 5 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2026

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT05369949

Start Date

January 5 2023

End Date

June 30 2026

Last Update

September 23 2022

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