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Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications | Clinical Trials | Clareo Health

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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

NCT07410988•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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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.

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

Key Dates

Start Date

April 1, 2026

Primary Completion Date

March 31, 2029

Completion Date

May 31, 2029

Last Updated

March 12, 2026

Enrollment

1,292

ESTIMATED participants

Conditions

Cardiac Surgery

Interventions

Volulyte® (6% HES 130/0.4 in balanced solution)

DRUG

Crystalloid solutions

DRUG

Contacts

Karam Nam, M.D., Ph.D.

CONTACT

+82 2 2072 0643 karamnam@gmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications

Inclusion Criteria

Exclusion Criteria

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