itric Oxide during Cardio Pulmonary Bypass during surgery for congenital heart defects: A Randomised Controlled Trial.

Phase 3

Completed

• Conditions: inflammation after congenital heart surgery; 10010394; 10007510; 10007593

• Registration Number: NL-OMON50652
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-07-05
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 82

Inclusion Criteria

- All infants and children < 2 years of age undergoing open heart surgery on CPB
- Elective cardiac surgery and consent of parents/guardian.

Exclusion Criteria

- Signs of persistently elevated pulmonary vascular resistance preoperatively
requiring iNO or preoperative use of intravenous drugs involved in the NO
pathway such as GTN, within 48 hours prior to CPB.- Patient is on ECLS prior to
surgery- Concurrent known confirmed bacterial sepsis/septic shock, diagnosed
within <48 hours prior to surgery and being actively treated with antibiotics
at time of surgery (suspected sepsis treated with antibiotics is not an
exclusion criteria unless inotropes are required for treatment of septic shock
at time of surgery)- Preoperative acute respiratory distress syndrome requiring
HFOV ventilation <48 hours of surgery- Patient requires high doses of
vasoactive drugs prior to surgery with an inotrope score >=15 met within 24
hours prior to surgery: Inotrope requirement will be calculated by means of the
Vasoactive-Inotrope Score (VIS) (2): VIS = dopamine dose (mcg/kg/min) +
dobutamine dose (mcg/kg/min) + 100 x adrenaline dose (mcg/kg/min) + 100 x
noradrenaline dose (mcg/kg/min) + 10 x milrinone dose (mcg/kg/min) + 10,000 x
vasopressin dose (U/kg/min).- Cardiac arrest within one week (7d) prior to
surgery- Emergency cardiac surgery which may preclude obtaining informed
consent (defined as acutely required life-saving procedure in a patient
unlikely to survive the next hours without the surgery)- Pre-existing
methaemoglobinemia (MetHb > 3%)X*t)
Strongly suspected or confirmed COVID-19

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Length of mechanical ventilation as defined as the duration of respiratory<br /><br>support for all episodes with an endotracheal tube in situ for the first 28<br /><br>days post randomisation. The outcome will be reported using ventilator free<br /><br>days (VFD). A systematically zero value will be assigned for patient who die to<br /><br>allow important weight to death as the most pejorative outcome.</p><br>