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New treatment option for AKI
Official title NO During CPB in Neonates to Reduce Risk of AKI
ClinicalTrials.gov ID: NCT04216927
What this study is testing
What is Nitric Oxide?
Nitric Oxide is an investigational medicine, being studied as a potential treatment for aki.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 31
You may be able to join if
- All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.
You likely can't join if
- Failure to obtain informed consent from parent/guardian
- Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
- Emergency surgery,
- Episode of cardiac arrest within 1 week before surgery,
- Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
- Use of inhaled NO (iNO) immediately prior to surgery,
See the full eligibility criteria
- All neonates (≤31 days) undergoing cardiac surgery with CPB for CHD will be deemed eligible for enrollment.
- Failure to obtain informed consent from parent/guardian
- Clinical signs of preoperative persistent elevated pulmonary vascular resistance,
- Emergency surgery,
- Episode of cardiac arrest within 1 week before surgery,
- Recent treatment with steroids and/or a condition that may require treatment with steroids (excluding steroid administration specifically for CPB),
- Use of inhaled NO (iNO) immediately prior to surgery,
- Structural renal abnormalities by ultrasound,
- Preoperative AKI,
- Use of other investigational drugs,
- Weight less than \<2 kg,
- Gestational age \<36 weeks,
- Major extracardiac congenital anomalies,
- Non-English speakers.
The study team makes the final eligibility decision.
Where it's taking place
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 day to 31 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.