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NOT YET RECRUITING

NCT06663254

PHASE4

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

Sponsor: Xiangya Hospital of Central South University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

410

Start Date

2024-11-30

Completion Date

2026-08-30

Last Updated

2024-10-29

Healthy Volunteers

Conditions

Perioperative Volume Replacement Hydroxyethyl Starch

Interventions

DRUG

Hydroxyethyl starch 130/0.4

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.

DRUG

Sodium acetate Ringer

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.

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.

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'an, Shanxi, China

Chaoyang Hospital of Capital Medical University

Beijing, China