Fluid choice during heart surgery: comparing HES to crystalloids
Official title: Effect of 130/0.4 Hydroxyethyl Starch vs. Balanced Crystalloid for Intraoperative Fluid Therapy on Major Composite Renal Outcomes After Cardiac Surgery: a Multicenter, Randomized Controlled Trial
Run by Seoul National University Hospital · NCT07410988 · Data updated 2026-11-12
This trial tests whether hydroxyethyl starch helps manage fluids during heart surgery without causing more kidney problems compared with balanced crystalloids.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 1292 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 4 sites (Daejeon and 3 other locations) |
| Status | Recruiting |
| Started | June 22, 2026 |
| Main results expected | June 30, 2029 |
| Study ends | July 31, 2029 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07410988 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 19 years or older scheduled for CABG, valve surgery, or thoracic aortic surgery.
✕Probably not a fit
Patients with emergency procedures, preexisting end-stage kidney disease requiring dialysis, or very low preoperative kidney function may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 4 interventional trial comparing two intraoperative fluids—Volulyte HES 6% and balanced crystalloids—in adults undergoing CABG, valve, or thoracic aortic surgery. The study measures major adverse kidney events after surgery to see which fluid approach maintains kidney function better. The trial uses standard intraoperative fluid administration aimed at preload and intravascular volume support. Participants are monitored for safety and kidney outcomes through postoperative follow-up.
Why it matters
Potential benefit: If successful, the findings could guide safer fluid choices during complex cardiac surgeries to protect kidney health.
How similar studies have gone: Prior research in fluid management during surgery has explored similar fluids, but conclusive benefits for kidney outcomes in this specific setting remain to be fully established.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Chungnam National University Hospital
Daejeon, South Korea Recruiting -
Korea University Guro Hospital
Seoul, South Korea Recruiting -
Seoul National University Hospital
Seoul, South Korea Recruiting -
Severance Hospital
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Karam Nam, M.D., Ph.D.
- Email: karamnam@gmail.com
- Phone: +82 2 2072 0643
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Impact of Fast-Track Anesthesia on Postoperative Delirium After Cardiac Surgery
This observational study tests whether fast-track anesthesia, compared with conventional care, is linked to lower rates of delirium after elective cardiac surgery in adults.
-
Sarcopenia in Patients After Cardiac Surgery
This observational study tests how common sarcopenia is after cardiac surgery and whether current care helps improve muscle mass and function.
-
Preoperative functional optimization for adults undergoing major cardiac or abdominal surgery
This study tests a four‑week prehabilitation program to improve fitness before elective major cardiac or abdominal surgery.
-
Oral Extubation Right After Cardiac Surgery
This trial tests whether waking patients and removing the breathing tube in the operating room after elective cardiac surgery helps recovery more quickly without added risk.
-
Frailty and Ultrasound-Guided Catheterization in Adult Cardiac Surgery Patients
This study tests whether frailty and ultrasound measurements taken before surgery can predict how difficult it will be to place an ultrasound-guided internal jugular venous catheter in adults undergoing elective cardiac surgery.
-
Prehabilitation before heart surgery for adults with congenital heart disease
This study is testing whether a tailored, supervised exercise program before heart surgery helps adults with congenital heart disease perform better and improve fitness.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.