NCT07410988

Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,292 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
DRUG	Volulyte® (6% HES 130/0.4 in balanced solution)	Hydroxyethyl starch is used (up to 20 mL/kg) when acute volume resuscitation is required (e.g., preload augmentation, intravascular volume replacement) during cardiac surgery.
DRUG	Crystalloid solutions	Balanced crystalloids are used instead of HES for the same indications as those in the HES group (when acute volume resuscitation is required \[e.g., preload augmentation, intravascular volume replacement\] during cardiac surgery).

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-03-31
• Completion: 2029-05-31
• First posted: 2026-02-13
• Last updated: 2026-03-12

Locations

4 sites across 1 country: South Korea