Clinical trial Recruiting at 4 sites Phase 4 Interventional Ages 19 and up

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

PhasePhase 4
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment1292 (estimated)
SponsorSeoul National University Hospital
Academic / other
Locations4 sites (Daejeon and 3 other locations)
StatusRecruiting
StartedJune 22, 2026
Main results expectedJune 30, 2029
Study endsJuly 31, 2029
Registry record updatedJuly 30, 2026
Trial IDNCT07410988 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.