Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Surgery
• Intervention / Treatment: Drug: Volulyte® (6% HES 130/0.4 in balanced solution); Drug: Crystalloid solutions

• Study Type: Interventional
• Enrollment (Estimated): 1292
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Karam Nam, M.D., Ph.D.; Phone Number: +82 2 2072 0643; Email: karamnam@gmail.com

Study Locations

• South Korea
  • Daejeon, South Korea, 35015
    • Chungnam National University Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
    • Contact: Karam Nam; Phone Number: +82 2 2072 0643; Email: karamnam@gmail.com
  • Seoul, South Korea, 03080
    • Korea University Guro Hospital
  • Seoul, South Korea, 03080
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydroxyethyl starch; 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	Drug: Volulyte® (6% HES 130/0.4 in balanced solution); 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.
Active Comparator: Ballanced crystalloid; 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).	Drug: Crystalloid solutions; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse kidney events (MAKE)	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).	For up to 7 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized average real variability	The sum of absolute differences between consecutive mean arterial pressure measurements, divided by the total monitoring duration from the first to the last measurement.	From intensive card unit admission after surgery to 6 hours post-admission
Peak increase in serum creatinine	the maximum increase in serum creatinine from the preoperative baseline during the first 3 postoperative days	From entollment to postoperative day 3
Maximum stage of acute kidney injury		From the end of surgery to postoperative day 7
Vasopressor-free days	The number of days alive and free from intravenous vasopressor support (e.g., dopamine, phenylephrine, epinephrine, norepinephrine, or vasopressin)	For up to 7 days post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative change in body weight	the difference between the first postoperative weight measurement and the most recent preoperative weight measurement (kg)	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.
Chest tube drainage during the first 12 hours after surgery (mL)	The cumulative volume of blood collected through the chest tube	The first 12 hours following the completion of surgery
Incidence of reoperation for postoperative bleeding control	The proportion of patients requiring an unplanned return to the operating room for the purpose of controlling hemorrhage after initial operating theater exit.	For up to 7 days post-surgery.
Plasma neutrophil gelatinase-associated lipocalin concentration		Measured once at the end of surgery
Time to extubation	the interval from postoperative intensive care unit admission until the planned removal of the endotracheal tube.	From the time of transfer to the ICU following surgery until ICU discharge, which occurs within 3-4 days postoperatively on average.
Incidence of major adverse kidney events		For up to 30 days post-surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: January 18, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hydroxyethyl starch
• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Dietary Carbohydrates; Carbohydrates; Isotonic Solutions; Solutions; Polysaccharides; Starch; Glucans; Hydroxyethyl Starch Derivatives; Crystalloid Solutions
• Other Study ID Numbers: SPROUT-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No