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Evaluation of hANP for prevention of acute kidney injury after cardiac surgery: A two-part randomized controlled trial with open-label extension in children aged 0–12 months.
EU CTIS ID: 2025-524069-26-00
What this study is testing
The primary objective of this trial is to evaluate whether hANP, compared with placebo, improves renal function in neonates (<1 month) and infants (1–12 months) undergoing cardiac surgery, measured as the change in creatinine clearance (CrCl) within 5 hours after initiation of treatment (T0–T1).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent from both legal guardians has been obtained (or deferred consent in urgent cases, as approved by the Ethics Committee).
- Infants (1–12 months): Chronological age 28 days to 12 months and postmenstrual age ≥42+0 weeks at time of inclusion. Neonates (<1 month): Postmenstrual age between 34+0 and 45+6 weeks at time of inclusion.
- Scheduled for cardiac surgery with cardiopulmonary bypass and postoperative admission to the PICU.
- On the first postoperative morning, meets risk of AKI defined as either: a. ≥25% decline in estimated creatinine clearance (eCrCl) (pRIFLE “Risk” or worse), or b. Fluid overload >10%.
- Weaning from CPB expected before 19:00 on the operation day.
- Patient has received at least one postoperative dose of loop diuretic (furosemide).
You likely can't join if
- Known hypersensitivity to hANP or any excipients in the investigational product.
- Severe hepatic dysfunction (clinically significant hepatic impairment judged by the investigator).
- Need for renal replacement therapy (RRT) postoperatively at the time of inclusion.
- Preoperative ECMO treatment or anticipated/required postoperative ECMO at the time of inclusion.
- Treatment with hANP preoperatively or postoperatively before POD1.
- Participation in another interventional clinical study within the last 30 days, if the intervention may, in the opinion of the investigator, interfere with study treatment, safety, or outcome assessment.
See the full eligibility criteria
- Written informed consent from both legal guardians has been obtained (or deferred consent in urgent cases, as approved by the Ethics Committee).
- Infants (1–12 months): Chronological age 28 days to 12 months and postmenstrual age ≥42+0 weeks at time of inclusion. Neonates (<1 month): Postmenstrual age between 34+0 and 45+6 weeks at time of inclusion.
- Scheduled for cardiac surgery with cardiopulmonary bypass and postoperative admission to the PICU.
- On the first postoperative morning, meets risk of AKI defined as either: a. ≥25% decline in estimated creatinine clearance (eCrCl) (pRIFLE “Risk” or worse), or b. Fluid overload >10%.
- Weaning from CPB expected before 19:00 on the operation day.
- Patient has received at least one postoperative dose of loop diuretic (furosemide).
- Known hypersensitivity to hANP or any excipients in the investigational product.
- Severe hepatic dysfunction (clinically significant hepatic impairment judged by the investigator).
- Need for renal replacement therapy (RRT) postoperatively at the time of inclusion.
- Preoperative ECMO treatment or anticipated/required postoperative ECMO at the time of inclusion.
- Treatment with hANP preoperatively or postoperatively before POD1.
- Participation in another interventional clinical study within the last 30 days, if the intervention may, in the opinion of the investigator, interfere with study treatment, safety, or outcome assessment.
- Admission to hospital less than 6 hours prior to start of surgery, indicating an ultra-acute clinical presentation without sufficient time for preoperative stabilization.
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.