Nitric Oxide for Congenital Heart Disease
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have recently been treated with steroids or are using inhaled nitric oxide (iNO) before surgery.
What evidence supports the effectiveness of the drug nitric oxide for congenital heart disease?
Inhaled nitric oxide is shown to be beneficial as a selective pulmonary vasodilator (a drug that widens blood vessels in the lungs) for treating pulmonary hypertension (high blood pressure in the lungs) in newborns with congenital heart disease, providing hemodynamic benefits (improvements in blood flow and pressure). However, these benefits have not been confirmed in randomized, placebo-controlled studies.12345
Is nitric oxide generally safe for use in humans?
Nitric oxide is involved in many body processes and has been studied for various conditions. It can cause side effects like headaches and low blood pressure due to its ability to widen blood vessels. However, it is generally considered safe when used appropriately, although targeting its effects to specific tissues remains a challenge.14567
How is the drug nitric oxide unique in treating congenital heart disease?
Nitric oxide is unique because it is inhaled and acts as a selective pulmonary vasodilator, meaning it specifically relaxes the blood vessels in the lungs, which can help manage pulmonary hypertension (high blood pressure in the lungs) in patients with congenital heart disease. This targeted action helps improve blood flow and oxygen delivery without affecting the rest of the body, unlike some other treatments.34589
What is the purpose of this trial?
Acute kidney injury (AKI) following cardiac surgery for congenital heart defects (CHD) in children affects up to 60% of high risk-patients and is a major cause of both short- and long-term morbidity and mortality. Despite effort, to date, no successful therapeutic agent has gained widespread success in preventing this postoperative decline in renal function. Nitric oxide is an intricate regulator of acute inflammation and coagulation and is a potent vasodilator. The investigators hypothesize that nitric oxide, administered during cardiopulmonary bypass (CPB), may reduce the incidence of AKI.
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Nitric oxide is administered during cardiopulmonary bypass (CPB) to reduce the incidence of AKI
Follow-up
Participants are monitored for AKI and other outcomes postoperatively
Extended Follow-up
Participants are monitored for long-term kidney function and recovery
Treatment Details
Interventions
- Nitric Oxide
Nitric Oxide is already approved in United States for the following indications:
- Hypoxic respiratory failure in term and near-term neonates with pulmonary hypertension
- Hypoxic respiratory failure in term and near-term neonates with pulmonary hypertension
- Hypoxic respiratory failure in term and near-term neonates with pulmonary hypertension
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Mallinckrodt
Industry Sponsor
Mario Saltarelli
Mallinckrodt
Chief Medical Officer
MD
Siggi Olafsson
Mallinckrodt
Chief Executive Officer
PhD in Pharmacy
Indiana University
Collaborator