NCT07410988 Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications
| NCT ID | NCT07410988 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Seoul National University Hospital |
| Condition | Cardiac Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,292 participants |
| Start Date | 2026-06-22 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,292 participants in total. It began in 2026-06-22 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial aims to compare two intraoperative fluids, namely hydroxyethyl starch (HES) and balanced crystalloids in terms of major adverse kidney events after cardiac surgery. Indications for the study fluids administarion include preload augmentation and intravascular volume replacement during cardiac surgery.
Eligibility Criteria
Inclusion Criteria: * Patients aged 19 years or older scheduled for coronary artery bypass grafting (CABG), heart valve surgery, and/or thoracic aortic surgery Exclusion Criteria: 1. Emergency surgery; 2. Planned implantation of a durable left ventricular assist device; 3. History of starch allergy or hypersensitivity; 4. History of kidney transplantation; 5. Preoperative end-stage renal disease (ESRD) or requirement for renal replacement therapy (RRT); 6. Preoperative glomerular filtration rate \< 30 mL/min/1.73 m2; 7. Planned intraoperative and postoperative RRT; 8. Preoperative use of mechanical circulatory support devices (e.g., intra-aortic balloon pump, extracorporeal membrane oxygenation, etc.); 9. Significant clinical coagulopathy (e.g., active bleeding disorder or thrombocytopenia with a platelet count \<100,000/µL); 10. Active infective endocarditis.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07410988 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Cardiac Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07410988 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07410988 currently recruiting?
Yes, NCT07410988 is actively recruiting participants. Contact the research team at karamnam@gmail.com for enrollment information.
Where is the NCT07410988 trial being conducted?
This trial is being conducted at Daejeon, South Korea, Seoul, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT07410988 clinical trial?
NCT07410988 is sponsored by Seoul National University Hospital. The trial plans to enroll 1,292 participants.