A randomised controlled trial of nitric oxide administration during cardiopulmonary bypass in neonates undergoing Arterial Switch Operation for repair of transposition of the great arteries.

A randomised controlled trial of nitric oxide administration during cardiopulmonary bypass in neonates undergoing Arterial Switch Operation for repair of transposition of the great arteries to evaluate an effect on major adverse events (death, ECMO, cardiac arrest)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000089235

Enrollment

Registered

2018-01-19

Start date

2018-05-25

Completion date

Unknown

Last updated

2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To test the hypothesis that addition of nitric oxide, a gas with anti-inflammatory properties, to the CPB circuit could improve post-operative outcome for children with transposition of the great arteries undergoing the arterial switch operation.

Interventions

Addition of 20 parts per million nitric oxide to the oxygenator of the cardiopulmonary bypass circuit for the duration of bypass

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

No minimum to 1 Months

Healthy volunteers

Inclusion criteria

• Neonate diagnosed with TGA requiring Arterial Switch Operation • Consent of parents/guardian.

Exclusion criteria

• Signs of persistently elevated pulmonary vascular resistance preoperatively requiring iNO or preoperative use of drugs involved in the NO pathway, such as nitro-glycerine, sildenafil • Requirement for ECLS prior to surgery • Concurrent viral or bacterial acute or chronic infection, including pulmonary conditions such as pneumonia • Pre-operative acute respiratory distress syndrome • Cardiac arrest prior to surgery • Prior surgical exposure to cardio-pulmonary bypass

Outcome results