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Vasodilator

Nitric Oxide for Congenital Heart Disease

Phase 3
Recruiting
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Must not have
Structural renal abnormalities by ultrasound
Emergency surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights
Pivotal Trial

Summary

This trial is testing whether nitric oxide can prevent acute kidney injury in children undergoing surgery for congenital heart defects.

Who is the study for?
This trial is for newborns (up to 31 days old) who need heart surgery with cardiopulmonary bypass for congenital heart defects. They must weigh over 2 kg and be at least 36 weeks gestational age. Babies can't join if they've had a recent cardiac arrest, preoperative AKI, certain lung or kidney conditions, steroid treatments, or are on other trials.
What is being tested?
The study tests whether nitric oxide given during heart surgery can lower the risk of acute kidney injury in newborns with congenital heart defects. It's exploring if this gas helps protect the kidneys by reducing inflammation and improving blood flow during surgery.
What are the potential side effects?
Nitric oxide may cause low blood pressure due to its vessel-widening effects, breathing difficulties if it affects oxygen levels in the blood, and possibly increase bleeding risks because of its effect on clotting.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My kidney ultrasound showed structural abnormalities.
Select...
I need surgery urgently.
Select...
I have had acute kidney injury before surgery.
Select...
My weight is under 2 kilograms.
Select...
I have high blood pressure in the lungs that hasn't improved before surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AKI
Secondary study objectives
Biomarker evidence of AKI - IL-18
Biomarker evidence of AKI - KIM-1
Biomarker evidence of AKI - L-FABP
+4 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nitric OxideExperimental Treatment1 Intervention
Intraoperative NO entrained at 20 ppm into the oxygenator of the CPB circuit with standard care
Group II: OxygenPlacebo Group1 Intervention
Standard CPB without NO administered at any point intraoperatively
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitric Oxide
2004
Completed Phase 4
~1280

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
834 Previous Clinical Trials
6,564,949 Total Patients Enrolled
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
15,826 Total Patients Enrolled
Indiana UniversityOTHER
1,037 Previous Clinical Trials
1,218,933 Total Patients Enrolled

Media Library

Nitric Oxide (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT04216927 — Phase 3
Congenital Heart Disease Research Study Groups: Oxygen, Nitric Oxide
Congenital Heart Disease Clinical Trial 2023: Nitric Oxide Highlights & Side Effects. Trial Name: NCT04216927 — Phase 3
Nitric Oxide (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04216927 — Phase 3
~2 spots leftby Dec 2024
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