Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period

Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period (T-NOX)

Sponsors

Lead Sponsor: University of Michigan

Source University of Michigan
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, patients that participate 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

Overall Status Recruiting
Start Date January 18, 2021
Completion Date August 2022
Primary Completion Date August 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Systemic oxidative stress based on thiobarbituric acid reactive substances (TBARS) Up to 24 hours following surgery
Rate of observed adverse events between the two groups 30 days after surgery
Post-operative length of stay 30 days after surgery
Days alive and out of the intensive care unit (ICU) at 30 days after surgery 30 days after surgery
Composite outcome of major adverse events 30 days after surgery
Global rank score 30 days after surgery
Enrollment 42
Condition
Intervention

Intervention Type: Other

Intervention Name: Normoxia (with controlled re-oxygenation)

Description: Participants will receive lower levels of oxygen during surgery and after surgery on the ventilator. As cardiopulmonary bypass is being weaned, anesthesia will initiate mechanical ventilation with an FiO2 of 50% or less (unless clinically necessary) to achieve oxygen saturation and PaO2 goals that fit within the expected range for the patient's physiology: Single ventricle patients (PaO2:35-45 and oxygen saturation 75%-85%) Two ventricle patients (PaO2: 60-100 and oxygen saturation >92%)

Arm Group Label: Normoxia

Intervention Type: Other

Intervention Name: Standard of care ventilation

Description: As cardiopulmonary bypass is being weaned, anesthesia will initiate mechanical ventilation per standard protocols. Ventilation will be continued in the ICU and adjusted per standard goals per the intensivist.

Arm Group Label: Standard of care

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

Gender: All

Minimum Age: N/A

Maximum Age: 29 Days

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Nathaniel Sznycer-Taub, MD Principal Investigator University of Michigan
Overall Contact

Last Name: Adriana Batazzi

Phone: 734-763-3140

Email: [email protected]

Location
Facility: Status: Contact: University of Michigan Adriana Batazzi 734-763-3140 [email protected]
Location Countries

United States

Verification Date

January 2021

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Michigan

Investigator Full Name: Nathaniel Sznycer-Taub

Investigator Title: Assistant Professor of Pediatrics

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Normoxia

Type: Experimental

Description: On bypass, goal PaO2 on cardiopulmonary bypass of 60-100 mm Hg using lower fraction of inspired oxygen (FiO2) (blended sweep gas) via oxygenator Post-bypass, goal of PaO2 <100 mm Hg by anesthesia and in ICU via oxygen titration via mechanical ventilator for 24 hours post-op.

Label: Standard of care

Type: Active Comparator

Description: Frequent blood gases will be checked per protocol on bypass and correlated with the blood parameter monitoring system to maintain a PaO2 of 200-300 per standard practice

Acronym T-NOX
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov

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