N/A
N=29
Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
Hypoplastic Left Heart Syndrome · Total Anomalous Pulmonary Venous Return · Truncus Arteriosus · Pulmonary Atresia With Ventricular Septal Defect · Transposition of the Great Arteries
Bottom Line
View on ClinicalTrials.gov: NCT04452188 ↗Enrolled (actual)
29
Serious AEs
20.7%
Results posted
Jun 2024
Primary outcome: Primary: Systemic Oxidative Stress Based on Thiobarbituric Acid Reactive Substances (TBARS) — 1.21; 1.93; 1.09; 1.77 Fold Change from Baseline — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Normoxia (with controlled re-oxygenation) (Other); Standard of care ventilation (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systemic Oxidative Stress Based on Thiobarbituric Acid Reactive Substances (TBARS) |
1.21; 1.93; 1.09; 1.77; 0.96; 1.41 | <0.01 sig |
| PRIMARY Rate of Observed Adverse Events Between the Two Groups |
1; 3; 1; 2; 1; 1 | — |
| PRIMARY Post-operative Length of Stay |
15; 15.5 | 0.66 |
| PRIMARY Days Alive and Out of the Intensive Care Unit (ICU) at 30 Days After Surgery |
22; 22.5 | 0.66 |
| PRIMARY Composite Outcome of Major Adverse Events |
3; 3 | 1.00 |
| PRIMARY Global Rank Score |
15; 17 | 0.49 |
Summary
This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery.
In addition to having the various doses of oxygen, participants will also have blood samples, ultrasounds of the head, and brain wave patterns monitored.
The hypotheses of this trial are:
* that there will be no difference with regards to adverse events between the infants in the normoxia group compared to the infants in the standard of care group
* there will be a significant difference in the measured partial pressure of oxygen (PaO2) values between the two treatment groups.
* the use of normoxia during cardiopulmonary bypass and in the immediate post-operative period will result in clinically significant decrease in oxidative stress as measured by thiobarbituric acid reactive substances (TBARS) after cardiac surgery
Eligibility Criteria
Inclusion Criteria
- Age less than 30 days of age at time of surgery with need for cardiopulmonary bypass with cardioplegic arrest (with or without deep hypothermic circulatory arrest)
- Diagnosis with cyanosis at baseline (pre-operative PaO2 of less than 50mmHG) due to:
- Complete admixture lesion (example: hypoplastic left heart syndrome, total anomalous pulmonary venous return, truncus arteriosus, pulmonary atresia with VSD)
- Transposition physiology (example: D-Transposition of the great arteries or Double outlet right ventricle with subpulmonary VSD)
- Right-to-left shunt (example: Tetralogy of Fallot, double outlet right ventricle with subaortic VSD and pulmonary stenosis)
Exclusion Criteria
- Corrected gestation at time of surgery less than 37 weeks
- Prior cardiac arrest
- Current or prior history of extracorporeal membrane oxygenation (ECMO) support
- Current or prior history of needing renal replacement therapy with dialysis
- Prior cardiac surgery requiring cardiopulmonary bypass
- Diagnosis of Ebstein's Anomaly
- Known genetic syndrome other than Trisomy 21 or DiGeorge Syndrome
Data sourced from ClinicalTrials.gov (NCT04452188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.