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

Phase 2

Completed

• Conditions: congenital heart disease; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery

• Registration Number: ACTRN12617000821392
• Lead Sponsor: A/Prof Andreas Schibler

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-05
• Study Completion: 2022-05-30
• Last Update Posted: 5 December 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1371

Inclusion Criteria

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

Exclusion Criteria

1. Signs of persistently elevated pulmonary vascular resistance preoperatively requiring iNO or preoperative use of drugs involved in the NO pathway such as GTN within 48 hours prior to CPB (oral sildenafil treatment alone is not an exclusion)
2. Patient is on ECLS immediately prior to surgery
3. Receiving ongoing treatment with antimicrobials for confirmed or suspected sepsis or septic shock diagnosed within 48hours prior to the time of surgery
4. Preoperative acute respiratory distress syndrome requiring HFOV ventilation within 48 hours prior to surgery
5. Patient requires high doses of vasoactive drugs prior to surgery with a score equal or greater than 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).
6. Cardiac arrest within one week (7d) prior to surgery
7. Emergency cardiac surgery (defined as acutely required life-saving procedure in a patient unlikely to survive the next 48hours without the surgery)
8. pre-existing methaemoglobinemia (MetHb>3%)
9. Patients that were previously enrolled and randomized into the study with surgical procedure performed that required use of cardio-pulmonary bypass will not get re-randomized. Previously enrolled and randomized patients will undergo the same treatment allocation for subsequent surgeries, unless parents opt out.
10. Chronic ventilator dependency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ength of mechanical ventilation as defined as the duration of respiratory support for all episodes with an endotracheal tube in situ for the first 28 days post start of cardiopulmonary bypass. The outcome will be reported using ventilator free days (VFD). A systematically zero value will be assigned for patients who die to allow important weight to death as the most pejorative outcome.[28 days post procedure]