Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications

NCT07410988 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: SPROUT-5
• Study Type: interventional
• Target: 1,292
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Cardiac Surgery

Keywords

hydroxyethyl starch

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Generalized average real variability

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

• Vasopressor-free days

  For up to 7 days post-surgery

• Peak increase in serum creatinine

  From entollment to postoperative day 3

• Maximum stage of acute kidney injury

  From the end of surgery to postoperative day 7

Other Outcomes (6)

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

  The first 12 hours following the completion of surgery

• Incidence of reoperation for postoperative bleeding control

  For up to 7 days post-surgery.

• Plasma neutrophil gelatinase-associated lipocalin concentration

  Measured once at the end of surgery

Study Arms (2)

Hydroxyethyl starch

EXPERIMENTAL

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)

Ballanced crystalloid

ACTIVE COMPARATOR

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

Interventions

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.

Hydroxyethyl starch

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).

Ballanced crystalloid

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (4)

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Korea University Guro Hospital

Seoul, 03080, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives; Crystalloid Solutions

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

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

CONTACT

+82 2 2072 0643; karamnam@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: February 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)