About this trial
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
This trial does not accept healthy volunteersQualifiers
Patients aged 19 years or older scheduled for coronary artery bypass grafting (CABG), heart valve surgery, and/or thoracic aortic surgery
Disqualifiers
Emergency surgery;
Planned implantation of a durable left ventricular assist device;
History of starch allergy or hypersensitivity;
History of kidney transplantation;
Trial design
Parallel
Treatments tested in this trial
Volulyte® (6% HES 130/0.4 in balanced solution)
DrugHydroxyethyl starch is used (up to 20 mL/kg) when acute volume resuscitation is required (e.g., preload augmentation, intravascular volume replacement) during cardiac surgery.
Crystalloid solutions
DrugBalanced 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).
Treatment groups
Trial outcomes
Primary outcomes
Incidence of major adverse kidney events (MAKE)
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 outcomes
Generalized average real variability
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
The number of days alive and free from intravenous vasopressor support (e.g., dopamine, phenylephrine, epinephrine, norepinephrine, or vasopressin)
Peak increase in serum creatinine
the maximum increase in serum creatinine from the preoperative baseline during the first 3 postoperative days
Maximum stage of acute kidney injury
Other outcomes
Chest tube drainage during the first 12 hours after surgery (mL)
The cumulative volume of blood collected through the chest tube
Incidence of reoperation for postoperative bleeding control
The proportion of patients requiring an unplanned return to the operating room for the purpose of controlling hemorrhage after initial operating theater exit.
Plasma neutrophil gelatinase-associated lipocalin concentration
Perioperative change in body weight
the difference between the first postoperative weight measurement and the most recent preoperative weight measurement (kg)
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