RecruitingPhase 4NCT07410988

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

Sponsor

Seoul National University Hospital

Enrollment

1,292 participants

Start Date

Jun 22, 2026

Study Type

INTERVENTIONAL

Conditions

Cardiac Surgery

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

Min Age: 19 Years

Inclusion Criteria1

Patients aged 19 years or older scheduled for coronary artery bypass grafting (CABG), heart valve surgery, and/or thoracic aortic surgery

Exclusion Criteria10

Emergency surgery;
Planned implantation of a durable left ventricular assist device;
History of starch allergy or hypersensitivity;
History of kidney transplantation;
Preoperative end-stage renal disease (ESRD) or requirement for renal replacement therapy (RRT);
Preoperative glomerular filtration rate < 30 mL/min/1.73 m2;
Planned intraoperative and postoperative RRT;
Preoperative use of mechanical circulatory support devices (e.g., intra-aortic balloon pump, extracorporeal membrane oxygenation, etc.);
Significant clinical coagulopathy (e.g., active bleeding disorder or thrombocytopenia with a platelet count <100,000/µL);
Active infective endocarditis.

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Interventions

DRUGVolulyte® (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.

DRUGCrystalloid 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).