NO During CPB in Neonates to Reduce Risk of AKI (NCT04216927) | Clinical Trial Compass
RecruitingPhase 3
NO During CPB in Neonates to Reduce Risk of AKI
United States40 participantsStarted 2023-01-10
Plain-language summary
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.
Who can participate
Age range
1 Day – 31 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether giving nitric oxide gas during the heart-lung bypass machine (CPB) can lower the risk of acute kidney injury in newborns having heart surgery — how likely is my baby to develop AKI after this type of surgery without the treatment, and does my baby's specific heart defect put them at higher or lower risk?
2Since this is a Phase 3 trial, what does that mean for how much is already known about the safety of inhaled nitric oxide in newborns during bypass, and are there any risks specific to using it in this age group that I should understand before deciding?
3How would my baby be monitored for signs of acute kidney injury during and after the surgery if they enroll in this trial, and does participating change anything about the standard post-operative care they would normally receive?
4If my baby is randomly assigned to the group that does not receive nitric oxide, would they still get everything that is considered standard care for protecting kidney function during and after heart surgery?
5Are there other approaches or standard treatments already being used at this hospital to reduce AKI risk in newborns during heart surgery, and how does this trial compare to what my baby would receive if we chose not to participate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AKI
Timeframe: 72 hours
Trial details
NCT IDNCT04216927
SponsorChildren's Hospital Medical Center, Cincinnati