In infants and children < 2 years of age with congenital heart defects, what is the effect of Nitric Oxide during open heart surgery with Cardio Pulmonary Bypass on postoperative length of mechanical ventilation? - A Randomised Controlled Trial.

A/Prof Andreas Schibler0 sites1,371 target enrollmentJune 5, 2017

Conditionscongenital heart disease Cardiovascular - Other cardiovascular diseases Surgery - Other surgery

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: congenital heart disease
Sponsor: A/Prof Andreas Schibler
Enrollment: 1371
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 5, 2017

End Date

May 30, 2022

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

A/Prof Andreas Schibler

Eligibility Criteria

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