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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,292
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).
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
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).
Time frame: For up to 7 days post-surgery; if hospital discharge occurs before Day 7, monitoring concludes at the time of discharge.
Incidence of all-cause mortality
The proportion of patients who die from any cause
Time frame: For up to 7 days post-surgery; if hospital discharge occurs before Day 7, monitoring concludes at the time of discharge.
Incidence of stage 2 or 3 acute kidney injury
Stage 2 AKI is defined as an increase in serum creatinine to 2.0-2.9 times the baseline value, and stage 3 AKI is defined as an increase in serum creatinine to ≥3.0 times the baseline value or to an absolute level of ≥4.0 mg/dL.
Time frame: For up to 7 days post-surgery; if hospital discharge occurs before Day 7, monitoring concludes at the time of discharge.
Incidence of new requirement for renal replacement therapy after surgery
The proportion of patients requiring de novo renal replacement therapy postoperatively among those who wererenal replacement therapy-naive before surgery.
Time frame: For up to 7 days post-surgery; if hospital discharge occurs before Day 7, monitoring concludes at the time of discharge.
Incidence of acute kidney injury
Defined as an increase in serum creatinine by ≥0.3 mg/dL within 48 h or to ≥1.5 times the baseline value within 7 days
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Time frame: For up to 7 days post-surgery; if hospital discharge occurs before Day 7, monitoring concludes at the time of discharge.
Incidence of all-cause 30-day mortality
The proportion of patients who dies from any cause within 30 days after surgery
Time frame: From the end of surgery to postoperative Day 30
Incidence of new requirement for renal replacement therapy within 30 days after surgery
New requirement for renal replacement therapy is defined as de novo renal replacement therapy after surgery among patients who were renal replacement therapy-naive before surgery.
Time frame: From the end of surgery to postoperative Day 30
Perioperative change in body weight
the difference between the first postoperative weight measurement and the most recent preoperative weight measurement (kg)
Time frame: From the most recent weight measurement before surgery until the first postoperative weight is recorded, typically spanning from the day before surgery to within several hours of the operation's completion.
Incidence of prolonged postoperative mechanical ventilation
The proportion of patients requiring mechanical ventilation for 24 hours or longer after surgery
Time frame: From the end of surgery until hospital discharge, an average of 1-2 weeks
Incidence of re-intubation after planned extubation during the postoperative period
The proportion of patients requiring re-insertion of an endotracheal tube following a planned extubation after the completion of surgery.
Time frame: From the time of planned extubation following surgery (typically within 1-2 days) until hospital discharge, which generally occurs within 1-2 weeks post-operation
Length of postoperative intensive care unit stay (days)
Time frame: From the time of transfer to the ICU following surgery until ICU discharge, which occurs within 3-4 days postoperatively on average.
Chest tube drainage during the first 12 hours after surgery (mL)
The cumulative volume of blood collected through the chest tube
Time frame: The first 12 hours following the completion of surgery
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.
Time frame: For up to 7 days post-surgery; if hospital discharge occurs before Day 7, monitoring concludes at the time of discharge.
Incidence of prolonged requirement for multiple vasoactive drugs support
The proportion of patients who require prolonged support with multiple vasoactive drugs (e.g., dopamine, dobutamine, epinephrine, norepinephrine, or milrinone), defined as the ongoing administration of two or more vasoactive agents at or beyond 24 hours after the end of surgery.
Time frame: From the completion of surgery until hospital discharge, which generally occurs within 1-2 weeks post-operation.