Clinical trial NCT04452188: Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period
Official title: Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period (T-NOX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoplastic Left Heart Syndrome
Total Anomalous Pulmonary Venous Return
Truncus Arteriosus
Pulmonary Atresia With Ventricular Septal Defect
Transposition of the Great Arteries
Double Outlet Right Ventricle, Subpulmonary VSD
Tetralogy of Fallot
Double Outlet Right Ventricle With Subaortic Ventricular Septal Defect and Pulmonary Stenosis
Cardiopulmonary Bypass
Keywords: Open heart surgery
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: National Institutes of Health (NIH)
First posted: 2020-06-30
Enrollment: 29
Sex: ALL
Maximum age (years): 29
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Systemic Oxidative Stress Based on Thiobarbituric Acid Reactive Substances (TBARS)
timeFrame: Up to 24 hours following surgery
measure: Rate of Observed Adverse Events Between the Two Groups
timeFrame: 30 days after surgery
measure: Post-operative Length of Stay
timeFrame: 30 days after surgery
measure: Days Alive and Out of the Intensive Care Unit (ICU) at 30 Days After Surgery
timeFrame: 30 days after surgery
measure: Composite Outcome of Major Adverse Events
timeFrame: 30 days after surgery
measure: Global Rank Score
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
measure: Systemic Oxidative Stress Based on Protein Carbonyl Levels After Surgery
timeFrame: Up to 24 hours after surgery
measure: Systemic Oxidative Stress Based on Total Antioxidant Capacity (TAC)
timeFrame: Up to 24 hours after surgery
measure: Systemic Oxidative Stress Based on 8-Isoprostane Levels After Surgery
timeFrame: Up to 24 hours after surgery
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Nathaniel Sznycer-Taub, MD
role: PRINCIPAL_INVESTIGATOR
References: