Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications
Recruiting
Phase 4Interventional Study
Cardiac Surgery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
1,292 (estimated)
Sponsor
Seoul National University Hospital · Other
Who this trial is looking for
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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.
Trial Locations
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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 aller…
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.
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