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Recruiting
NCT07410988
Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications
Conditions: Cardiac Surgery
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 1292
Sponsor: Seoul National University Hospital
Location: Chungnam National University Hospital Daejeon
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 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 \
Source: ClinicalTrials.gov (NCT07410988). StuddyBuddy aggregates publicly available trial information.