Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2021-10-31
2023-03-31
Brief Summary
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Detailed Description
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Research Sample Collection: Blood and urine will be collected for the first 48 hours admission and analyzed. The specific time points for these parameters will be: 2 hours, 6 hours, 12 hours 24 hours, and 48 hours post admission. Blood and urine parameters will also be collected as a baseline pre-operative. Patient outcomes will be captured for 30 days post operatively.
Research Data Collection: Baseline information will be collected. Other research related variables collected during the surgical intervention and bypass. Additional information will be collected 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after admission as well as outcomes 30 days after the procedure.
Participants will be randomly allocated to the NO or control group in a 1:1 ratio.
This study is investigating a possible protective role for NO gas administration during bypass on the subsequent development of AKI. NO is typically delivered via large, stand-alone cylinders that are placed at the bedside (or adjacent to the patient) and is set up by respiratory therapists. In this research study, the study gas (NO or placebo) will be delivered directly into the bypass circuit at a constant gas flow. The placebo gas in this study will be 21% (or atmospheric) oxygen, and will appear to all members of the clinical and research teams (with the exception of the respiratory therapist responsible for setting it up) indistinguishable from NO, rendering this a double-blind study for the patient (or caregiver) and the investigators. This minimizes any possibility of bias in the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NO Group
NO gas delivered during cardiac surgery
intra-operative NO gas at 20ppm blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system.
Placebo Group
placebo gas delivered during cardiac surgery
placebo blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system. The placebo gas in this study will be 21% (or atmospheric) oxygen.
Interventions
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NO gas delivered during cardiac surgery
intra-operative NO gas at 20ppm blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system.
placebo gas delivered during cardiac surgery
placebo blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system. The placebo gas in this study will be 21% (or atmospheric) oxygen.
Eligibility Criteria
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Inclusion Criteria
* Gestational age: 38 weeks
* Diagnosis: Congenital Heart Disease (CHD)
* Planned surgery to include cardiopulmonary bypass (CPB )for underlying CHD
* Consent of parent/guardian
Exclusion Criteria
* Pre-existing acute kidney injury (AKI) as per the AKIN criteria;
* Cardiac arrest within one week prior consent;
* Prior cardiac surgery with CPB procedure;
* Prior history of Extra Corporeal Membrane Oxygenation (ECMO)
* Use of another investigational drug.
30 Days
ALL
No
Sponsors
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Mallinckrodt
INDUSTRY
Fabio Savorgnan
OTHER
Responsible Party
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Fabio Savorgnan
Principal Investigator / Assistant Professor
Principal Investigators
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Fabio Savorgnan, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Children's Hospital / Baylor College of Medicine
Locations
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Texas Children's Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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H-44435
Identifier Type: -
Identifier Source: org_study_id