Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07410988

Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications

This trial aims to compare two intraoperative fluids, namely hydroxyethyl starch (HES) and balanced crystalloids in terms of major adverse kidney events after cardiac surgery. Indications for the study fluids administarion include preload augmentation and intravascular volume replacement during cardiac surgery.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cardiac Surgery

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chungnam National University Hospital, Daejeon, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 19 years or older scheduled for coronary artery bypass grafting (CABG), heart valve surgery, and/or thoracic aortic surgery

Exclusion criteria

  • Emergency surgery;
  • Planned implantation of a durable left ventricular assist device;
  • History of starch allergy or hypersensitivity;
  • History of kidney transplantation;
  • Preoperative end-stage renal disease (ESRD) or requirement for renal replacement therapy (RRT);
  • Preoperative glomerular filtration rate < 30 mL/min/1.73 m2;
  • Planned intraoperative and postoperative RRT;
  • Preoperative use of mechanical circulatory support devices (e.g., intra-aortic balloon pump, extracorporeal membrane oxygenation, etc.);
  • Significant clinical coagulopathy (e.g., active bleeding disorder or thrombocytopenia with a platelet count <100,000/µL);
  • Active infective endocarditis.

Treatment and study plan

Volulyte® (6% HES 130/0.4 in balanced solution)

Drug

Hydroxyethyl starch is used (up to 20 mL/kg) when acute volume resuscitation is required (e.g., preload augmentation, intravascular volume replacement) during cardiac surgery.

Crystalloid solutions

Drug

Balanced crystalloids are used instead of HES for the same indications as those in the HES group (when acute volume resuscitation is required [e.g., preload augmentation, intravascular volume replacement] during cardiac surgery).

Primary outcomes

  1. Incidence of major adverse kidney events (MAKE)

    Time frame: For up to 7 days post-surgery

    The incidence of a composite outcome consinsting of all-cause mortality (patients who dies from any cause after surgery), stage 2 (an increase in serum creatinine to 2.0-2.9 times the baseline value) or stage 3 (an increase in serum creatinine to ≥3.0 times the baseline value or to an absolute level of ≥4.0 mg/dL) acute kidney injury, or new requirement for renal replacement therapy (de novo renal replacement therapy after surgery among patients who were renal replacement therapy-naive before surgery).

Secondary outcomes

  1. Generalized average real variability

    Time frame: From intensive card unit admission after surgery to 6 hours post-admission

    The sum of absolute differences between consecutive mean arterial pressure measurements, divided by the total monitoring duration from the first to the last measurement.

  2. Vasopressor-free days

    Time frame: For up to 14 days post-surgery

    The number of days alive and free from intravenous vasopressor support (e.g., dopamine, phenylephrine, epinephrine, norepinephrine, or vasopressin)

  3. Peak increase in serum creatinine

    Time frame: From entollment to postoperative day 3

    the maximum increase in serum creatinine from the preoperative baseline during the first 3 postoperative days

  4. Maximum stage of acute kidney injury

    Time frame: From the end of surgery to postoperative day 7

Other outcomes

  1. Chest tube drainage during the first 12 hours after surgery (mL)

    Time frame: The first 12 hours following the completion of surgery

    The cumulative volume of blood collected through the chest tube

  2. Incidence of reoperation for postoperative bleeding control

    Time frame: For up to 7 days post-surgery.

    The proportion of patients requiring an unplanned return to the operating room for the purpose of controlling hemorrhage after initial operating theater exit.

  3. Plasma neutrophil gelatinase-associated lipocalin concentration

    Time frame: Measured once at the end of surgery

  4. Perioperative change in body weight

    Time frame: From the most recent weight measurement before surgery until the first postoperative weight is recorded, typically spanning from the day before surgery to within several hours of the operation's completion.

    the difference between the first postoperative weight measurement and the most recent preoperative weight measurement (kg)

  5. Time to extubation

    Time frame: From the time of transfer to the ICU following surgery until ICU discharge, which occurs within 3-4 days postoperatively on average.

    the interval from postoperative intensive care unit admission until the planned removal of the endotracheal tube.

  6. Incidence of major adverse kidney events

    Time frame: For up to 30 days post-surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Karam Nam, M.D., Ph.D.

CONTACT

[email protected]

+82 2 2072 0643

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of 130/0.4 Hydroxyethyl Starch vs. Balanced Crystalloid for Intraoperative Fluid Therapy on Major Composite Renal Outcomes After Cardiac Surgery: a Multicenter, Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 13, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.