The investigators propose a multicenter randomized trial to test the renal safety of 6% hydroxyethyl starch (HES) 130/0.4 combined with sodium acetate Ringer's crystalloid solution in moderate-to-high cardiovascular risk patients having major abdominal surgery. The reference group will only be given sodium acetate Ringer's crystalloid.
The investigators propose a multicenter randomized trial to test the renal safety of 6% hydroxyethyl starch (HES) 130/0.4 combined with sodium acetate Ringer's crystalloid solution in moderate-to-high cardiovascular risk patients having major abdominal surgery. The reference group will only be given sodium acetate Ringer's crystalloid. The investigators will test the primary hypothesis that the maximum decrease in serum Cystatin-C-based estimated glomerular filtration rate (eGFR) from preoperatively through the initial 3 postoperative hospital days is non-inferior in patients who are randomized to a goal-directed combination of HES and crystalloid volume replacement versus goal-directed crystalloid alone. Secondarily, the investigators will determine the long-term renal safety (cystatin C-based eGFR on postoperative 1 and 3 months) of HES and its effect on major adverse cardiovascular events and the length of hospitalization. Exploratory outcomes will include intraoperative hemodynamic indices, postoperative gastrointestinal indicators, the rate of unscheduled transferring to intensive care unit, the incidence of hospital re-admission within 30 days, the incidence of renal replacement therapy within 90 days after surgery, and the incidence of acute kidney injury based on serum creatine within 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
410
Individualized goal-directed administration of 6% Hydroxyethyl starch (HES) 130/0.4: After the induction of anesthesia, 200 ml trial fluid will be infused over 20 min. If stroke volume (SV) increases \>10%, another 200 ml fluid will be given. After that, the use of trial fluid will be determined by the patients' Stroke Volume Variation (SVV). If the SVV exceeds 12%, 200 ml trial fluid will be given over 20 min; this will be repeated until SVV \<12%. If the use of HES exceeds 30 ml/kg, sodium acetate Ringer will be replaced. In addition, patients will have a background infusion of sodium acetate Ringer's solution at 4 ml/kg/h to satisfy the maintenance fluid requirements during surgery.
Individualized goal-directed administration of crystalloid alone: After the induction of anesthesia, 200 ml trial fluid will be infused over 20 min. If stroke volume (SV) increases \>10%, another 200 ml fluid will be given. After that, the use of trial fluid will be determined by the patients' Stroke Volume Variation (SVV). If the SVV exceeds 12%, 200 ml trial fluid will be given over 20 min; this will be repeated until SVV \<12%. In addition, patients will have a background infusion of sodium acetate, the maintenance fluid requirement during surgery.
The First Affiliated Hospital of Zhengzhou University;
Zhengzhou, Henan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi, China
Chaoyang Hospital of Capital Medical University
Beijing, China
Maximum change in serum Cystatin-C based estimated glomerular filtration rate (eGFR) from baseline through initial 3 postoperative hospital days
The decrease in cystatin-C-based eGFR from preoperatively to the minimum value recorded during the initial three postoperative hospital days. Increases in postoperative eGFR will be considered a reduction of 0 for analysis purposes.
Time frame: Baseline and postoperative 1/2/3 day
Cystatin-C based eGFR on postoperative 1 month
The absolute value of cystatin-C based eGFR on postoperative 1 month.
Time frame: Postoperative 1 month
Cystatin-C based eGFR on postoperative 3 months
The absolute value of cystatin-C based eGFR on postoperative 3 months.
Time frame: Postoperative 3 months
Postoperative major adverse cardiovascular events composite
Major adverse cardiovascular events are a composite of all-cause mortality or one or more of the following cardiovascular complications occurring within 30 days after surgery: myocardial injury after non-cardiac surgery (MINS), non-fatal cardiac arrest, stroke, ventricular arrhythmia requiring treatment.
Time frame: Postoperative 30 days
The length of hospitalization
Time frame: Postoperative 3 month
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