Cardiac Surgery
Conditions
Keywords
hydroxyethyl starch
Brief 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.
Interventions
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.
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).
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of major adverse kidney events (MAKE) | For up to 7 days post-surgery | The incidence of a composite outcome consinsting of all-cause mortality (patients who dies from any cause after surgery), stage 2 (an increase in serum creatinine to 2.0-2.9 times the baseline value) or stage 3 (an increase in serum creatinine to ≥3.0 times the baseline value or to an absolute level of ≥4.0 mg/dL) acute kidney injury, or new requirement for renal replacement therapy (de novo renal replacement therapy after surgery among patients who were renal replacement therapy-naive before surgery). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized average real variability | From intensive card unit admission after surgery to 6 hours post-admission | The sum of absolute differences between consecutive mean arterial pressure measurements, divided by the total monitoring duration from the first to the last measurement. |
| Vasopressor-free days | From intensive care unit admission after surgery to postoperative day 14 | The number of days alive and free from intravenous vasopressor support (e.g., dopamine, phenylephrine, epinephrine, or norepinephrine) |
| Peak increase in serum creatinine | From entollment to postoperative day 3 | the maximum increase in serum creatinine from the preoperative baseline during the first 3 postoperative days |
| Maximum stage of acute kidney injury | From the end of surgery to postoperative day 7 | — |
Countries
South Korea
Contacts
CONTACTKaram Nam, M.D., Ph.D.
Outcome results
None listed