Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period (T-NOX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04452188|
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : September 9, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|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||Other: Normoxia (with controlled re-oxygenation) Other: Standard of care ventilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period (T-NOX)|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
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.
Other: Normoxia (with controlled re-oxygenation)
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:
Active Comparator: Standard of care
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
Other: Standard of care ventilation
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.
- Systemic oxidative stress based on thiobarbituric acid reactive substances (TBARS) [ Time Frame: Up to 24 hours following surgery ]This will be assessed at three separate time points in the first 24 hours after surgery (2, 6, and 24 hours). An analysis of co-variance will be used incorporating all available data to model the outcome with an adjustment for pre-operative baseline. The model will compare the mean values (and 95% confidence intervals) between the two groups at each time-point.
- Rate of observed adverse events between the two groups [ Time Frame: 30 days after surgery ]The composite with any of the following outcomes within 30 days after the index cardiac surgery: mortality, cardiac arrest, need for mechanical circulatory support, seizures (clinical or subclinical based on EEG), and need for dialysis. These will be compared between both treatment groups using Chi-square test or Fisher's exact test as appropriate.
- Post-operative length of stay [ Time Frame: 30 days after surgery ]Calculated as number of days in the hospital after surgery.
- Days alive and out of the intensive care unit (ICU) at 30 days after surgery [ Time Frame: 30 days after surgery ]
- Composite outcome of major adverse events [ Time Frame: 30 days after surgery ]
- Global rank score [ Time Frame: 30 days after surgery ]Scores will be calculated based on a pre-specified ranking of outcomes: mortality, cardiac arrest, extracorporeal membrane oxygenation (ECMO), seizures, and dialysis. This study will also explore the inclusion of other clinical endpoints in both the global rank score and composite outcome, as well as different ranking strategies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452188
|Contact: Adriana Batazziemail@example.com|
|Contact: Nathaniel Sznycer-Taub, MDfirstname.lastname@example.org|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Adriana Batazzi 734-763-3140 email@example.com|
|Principal Investigator:||Nathaniel Sznycer-Taub, MD||University of Michigan|