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NOT YET RECRUITING
NCT07410988
PHASE4

Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1292

Start Date

2026-04-01

Completion Date

2029-05-31

Last Updated

2026-03-12

Healthy Volunteers

No

Conditions

Interventions

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).

Locations (4)

Chungnam National University Hospital

Daejeon, South Korea

Korea University Guro Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea