Clinical trial NCT06663254: Safety and Efficacy of Perioperative Volume Replacement with Volulyte 6% in Moderate-to-high Cardiovascular Risk Patients Having Major Abdominal Surgery
Official title: Safety and Efficacy of Perioperative Volume Replacement with Volulyte 6% in Moderate-to-high Cardiovascular Risk Patients Having Major Abdominal Surgery: a Parallel-group, Double-blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Perioperative Volume Replacement
Hydroxyethyl Starch
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 410
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Are at least 45 years old;
* Scheduled for elective open or laparoscopic gastrointestinal surgery expected to last ≥2 hours;
* Having general anesthesia;
* Expected to require at least overnight hospitalization;
* Subject to at least one of the following risk factors:

  1. Age ≥65 years;
  2. History of peripheral arterial disease;
  3. History of coronary artery disease;
  4. History of stroke or transient ischemic attack;
  5. Diabetes requiring medication;
  6. Current smoking or 15-pack-year history of smoking tobacco;
  7. Body mass index ≥30 kg/m2;
  8. Preoperative high-sensitivity troponin T ≥14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay), 19 ng/L (Siemens assay), or 25% of the 99% percentile for other assays - all within 6 months;
  9. B-type natriuretic protein (BNP) ≥80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) ≥200 ng/L within six months.

Exclusion Criteria:

* Participate in conflicting studies;
* Are designated American Society of Anesthesiologists physical status 4;
* Are pregnant and/or breastfeeding;
* Have hypoproteinemia (serum albumin \<30 g/L) or were given preoperative intravenous colloids, including albumin;
* Have recent intracranial or cerebral hemorrhage;
* Have preoperative acute kidney injury or chronic renal insufficiency (Serum Creatine ≥140 µmol/L for men, Serum Creatine≥120 µmol/L for women and/or oliguria/anuria) or renal replacement therapy;
* Have severe hepatic impairment (Alanine Transaminase (ALT) and/or Aspartate Aminotransferase (AST) more than two times the upper limit of normal);
* Are in congestive heart failure or have pulmonary edema;
* Are critically ill or septic;
* Have electrolyte disorders such as hypernatremia, hyperchloremia, hyperkalemia, or severe alkalosis;
* Are fluid overloaded or dehydrated;
* Have clinically meaningful coagulation or bleeding disorders;
* Had a solid organ transplant;
* Have a current serious burn injury;
* Have a mental illness that precludes adequate consent or cooperation with the proposed trial;
* Have known hypersensitivity or contraindication to Volulyte 6% or any sodium acetate Ringer solution component.

Primary outcomes:
measure: Maximum change in serum Cystatin-C based estimated glomerular filtration rate (eGFR) from baseline through initial 3 postoperative hospital days
timeFrame: Baseline and postoperative 1/2/3 day
Secondary outcomes:
measure: Cystatin-C based eGFR on postoperative 1 month
timeFrame: Postoperative 1 month
measure: Cystatin-C based eGFR on postoperative 3 months
timeFrame: Postoperative 3 months
measure: Postoperative major adverse cardiovascular events composite
timeFrame: Postoperative 30 days
measure: The length of hospitalization
timeFrame: Postoperative 3 month
Other outcomes:
measure: Average cardiac index
timeFrame: Perioperative
measure: Responses to boluses of each fluid
timeFrame: Perioperative
measure: Total fluid volume
timeFrame: Perioperative and the subsequent first 24 postoperative hours
measure: Generalized average real variability of mean arterial pressure
timeFrame: Perioperative
measure: Time to first defecation
timeFrame: Postoperative 30 days
measure: Time to tolerance of oral liquid diet
timeFrame: Postoperative 30 days
measure: Postoperative gastrointestinal complications
timeFrame: Postoperative 30 days
measure: Hospital re-admission within 30 days
timeFrame: Postoperative 30 days
measure: The rate of unscheduled transferring to intensive care unit (ICU)
timeFrame: Postoperative 30 days
measure: the incidence of acute kidney injury based on available serum creatine
timeFrame: Postoperative 7 days
measure: The incidence of renal replacement therapy within 90 days after surgery
timeFrame: Postoperative 3 month
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University;
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospital
state: Shandong
city: Xi&#39;an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Beijing
country: China
facility: Chaoyang Hospital of Capital Medical University
Study officials:
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