Safety and Efficacy of Perioperative Volume Replacement with Volulyte 6% in Moderate-to-high Cardiovascular Risk Patients Having Major Abdominal Surgery

Phase 4

Not yet recruiting

• Conditions: Perioperative Volume Replacement; Hydroxyethyl Starch
• Interventions: Drug: Hydroxyethyl starch 130/0.4; Drug: Sodium acetate Ringer

• Registration Number: NCT06663254
• Lead Sponsor: Xiangya Hospital of Central South University

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Study Start: 2024-11-30
• Primary Completion: 2026-03-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 410

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6% hydroxyethyl starch 130/0.4	Hydroxyethyl starch 130/0.4	-
Sodium acetate Ringer	Sodium acetate Ringer	-

Primary Outcome Measures

Name	Time	Method
Maximum change in serum Cystatin-C based estimated glomerular filtration rate (eGFR) from baseline through initial 3 postoperative hospital days	Baseline and postoperative 1/2/3 day	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.

Secondary Outcome Measures

Name	Time	Method
Cystatin-C based eGFR on postoperative 1 month	Postoperative 1 month	The absolute value of cystatin-C based eGFR on postoperative 1 month.
Cystatin-C based eGFR on postoperative 3 months	Postoperative 3 months	The absolute value of cystatin-C based eGFR on postoperative 3 months.
Postoperative major adverse cardiovascular events composite	Postoperative 30 days	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.
The length of hospitalization	Postoperative 3 month

Trial Locations

Locations (6)

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&#39;an, Shanxi, China

Chaoyang Hospital of Capital Medical University; 🇨🇳 Beijing, China