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RESCAP to prevent peri- and post-surgical complications in open-heart surgery.
EU CTIS ID: 2025-520551-84-00
What this study is testing
First primary endpoint Demonstrate that RESCAP® intervention reduces the time to reach stability, while at ICU. Severity of illness is assessed using the SOFA (Sequential Organ Failure Assessment) score over 12 days while the patient remains in the ICU. Outcome will be compared after 72 hours in the ICU. Second primary composite endpoint Demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass as defined by the AKIN criteria. Rise in serum creatinine of by 0.3 mg/dl or 26 μmol/L in 48 hours/ a percentage increase in the serum creatinine concentration of ≥50 percent 10 or A drop in urine output to 0.5 ml/kg/hour for 6 hours Occurrence of acute kidney injury will be checked within 30 days and additionally after 90 after surgery.
- Therapeutic confirmatory (Phase III)
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
- > 21 years of age (legal adult in Singapore)
- Undergoing cardiac surgery with planned cardiopulmonary bypass
- EuroSCORE II >= 3
- Ability to provide informed consent (not incapacitated)
- Patient has given written informed consent prior to participation in the trial and undertakes to comply with the protocol.
You likely can't join if
- Already on renal replacement therapy
- Patients with chronic kidney disease defined as urinary albumin excretion of ≥30 mg/day, or equivalent or estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m2 for > 3 months.
- Patients who are pregnant or lactating
- Concurrent enrolment in another clinical trial
- Known allergic reaction to bovine alkaline phosphatase
- Patient with ongoing infections or current use of steroids
See the full eligibility criteria
- > 21 years of age (legal adult in Singapore)
- Undergoing cardiac surgery with planned cardiopulmonary bypass
- EuroSCORE II >= 3
- Ability to provide informed consent (not incapacitated)
- Patient has given written informed consent prior to participation in the trial and undertakes to comply with the protocol.
- Already on renal replacement therapy
- Patients with chronic kidney disease defined as urinary albumin excretion of ≥30 mg/day, or equivalent or estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m2 for > 3 months.
- Patients who are pregnant or lactating
- Concurrent enrolment in another clinical trial
- Known allergic reaction to bovine alkaline phosphatase
- Patient with ongoing infections or current use of steroids
- Patient with high-risk emergency surgery or with follow-up procedures already planned at admission (like e.g., TEVAR)
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, 18-64 years, 65+ 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.