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

October 25, 2024 updated by: Xiangya Hospital of Central South University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

410

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Chaoyang Hospital of Capital Medical University
        • Contact:
          • Director, Department of Anesthesiology
          • Phone Number: +86-010-85231777
    • Henan
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University;
        • Contact:
          • Director, Department of Anesthesiology
          • Phone Number: +86-0371-67966266
    • Hunan
      • Changsha, Hunan, China, 410008
        • Xiangya Hospital of Central South University
        • Contact:
        • Contact:
          • E Wang
    • Liaoning
      • Shenyang, Liaoning, China
        • The First Hospital of China Medical University
        • Contact:
          • Director, Department of Anesthesiology
          • Phone Number: +86-024-961200
    • Shandong
      • Jinan, Shandong, China
        • Shandong Provincial Qianfoshan Hospital
        • Contact:
          • Director, Department of Anesthesiology
          • Phone Number: +86-0531-89268763
    • Shanxi
      • Xi'an, Shanxi, China
        • The First Affiliated Hospital Of Xi'an Jiaotong University
        • Contact:
          • Director, Department of Anesthesiology
          • Phone Number: +86-029-85323112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 6% hydroxyethyl starch 130/0.4
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.
Other Names:
  • Volulyte 6%
  • 6% Hydroxyethyl starch 130/0.4
Other: Sodium acetate Ringer
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average cardiac index
Time Frame: Perioperative
Perioperative
Responses to boluses of each fluid
Time Frame: Perioperative
The average difference between the cardiac index measured before a bolus is given and of the cardiac index measured 30 after the beginning of each bolus.
Perioperative
Total fluid volume
Time Frame: Perioperative and the subsequent first 24 postoperative hours
Total fluid volume (sodium Acetate Ringer and 6% hydroxyethyl starch 130/0.4) given during anesthesia and the subsequent first 24 postoperative hours.
Perioperative and the subsequent first 24 postoperative hours
Generalized average real variability of mean arterial pressure
Time Frame: Perioperative
Perioperative
Time to first defecation
Time Frame: Postoperative 30 days
Postoperative 30 days
Time to tolerance of oral liquid diet
Time Frame: Postoperative 30 days
Postoperative 30 days
Postoperative gastrointestinal complications
Time Frame: Postoperative 30 days
Postoperative gastrointestinal complications occurring by day 30 after surgery (defined as the need for surgical reoperation): anastomotic leakage, leakage of the rectum, intestinal obstruction, peritonitis, necrosis of stoma, et, at. which need reoperation or endoscopic drainage.
Postoperative 30 days
Hospital re-admission within 30 days
Time Frame: Postoperative 30 days
Postoperative 30 days
The rate of unscheduled transferring to intensive care unit (ICU)
Time Frame: Postoperative 30 days
Postoperative 30 days
the incidence of acute kidney injury based on available serum creatine
Time Frame: Postoperative 7 days
Postoperative 7 days
The incidence of renal replacement therapy within 90 days after surgery
Time Frame: Postoperative 3 month
Postoperative 3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 30, 2024

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XiangyaHMZKHES
  • 2024060725 (Other Identifier: Xiangya Hospital Medical Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for individual participant data meta-analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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