The addition of nitric oxide to cardiopulmonary bypass in children - a randomised controlled trial

Phase 3

Completed

• Conditions: low cardiac output syndrome; congenital heart disease; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery

• Registration Number: ACTRN12615001376538
• Lead Sponsor: Intensive Care Unit, Royal Childrens' Hospital, Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

any child undergoing cpb for congenital heart disease

Exclusion Criteria

emergency cases
children requiring inhaled nitric oxide prior to surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with low cardiac output was the specific primary outcome.<br>This was defined as a (on ICU) a blood lactate >4 with mixed venous saturation <60% OR vasoactive inotrope score greater or equal to 10 (ie a high inotrope requirement), OR need for ECMO support.[within 48 hrs of admission to icu post-operative]

Secondary Outcome Measures

Name	Time	Method
Duration of ventilation <br>Assessed by review of hospital records [Total time on ventilation during ICU stay];ICU length of stay<br>Assessed by review of hospital records[Time from ICU admission following surgery to ICU discharge];Hospital length of stay<br>Assessed by review of hospital records[Time from end of procedure to hospital discharge]