Cardiac SurgeryPhase 4NCT07410988
Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications
A Phase 4 study testing Volulyte® (6% HES 130/0.4 in balanced solution) and Crystalloid solutions in people with Cardiac Surgery, run by Seoul National University Hospital at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Volulyte® (6% HES 130/0.4 in balanced solution) and Crystalloid solutions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,292 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 22 Jun 2026to 31 Jul 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 years or older scheduled for coronary artery bypass grafting (CABG), heart valve surgery, and/or thoracic aortic surgery
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Chungnam National University Hospital
Daejeon, 35015
- Recruiting
Korea University Guro Hospital
Seoul, 03080
- Recruiting
Seoul National University Hospital
Seoul, 03080
Karam Nam, +82 2 2072 0643, karamnam@gmail.com
- Recruiting
Severance Hospital
Seoul, 03080
About this study
Official 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
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
- Being tested
- Volulyte® (6% HES 130/0.4 in balanced solution), Crystalloid solutions
- Keywords
- hydroxyethyl starch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 solutionsDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Drug: Crystalloid solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: For up to 7 days post-surgery
Secondary outcomes (4)
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.
Measured: From intensive card unit admission after surgery to 6 hours post-admission
Vasopressor-free days
The number of days alive and free from intravenous vasopressor support (e.g., dopamine, phenylephrine, epinephrine, norepinephrine, or vasopressin)
Measured: For up to 14 days post-surgery
Peak increase in serum creatinine
the maximum increase in serum creatinine from the preoperative baseline during the first 3 postoperative days
Measured: From entollment to postoperative day 3
Maximum stage of acute kidney injury
Measured: From the end of surgery to postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start22 Jun 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karam Nam, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410988
- Sponsor's protocol ID
- SPROUT-5
- Status last verified
- Jul 2026
- First submitted
- 18 Jan 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07410988
- Acronym / sponsor ID
- SPROUT-5
- Conditions
- Cardiac Surgery
- Keywords
- hydroxyethyl starch
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,292 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxyethyl starch | Experimental | 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 |
| Ballanced crystalloid | Active comparator | Drug: Crystalloid solutionsBalanced 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). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 19 years or older scheduled for coronary artery bypass grafting (CABG), heart valve surgery, and/or thoracic aortic surgery
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Hydroxyethyl starch |
| Crystalloid solutionsBalanced 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 | Ballanced crystalloid |
Primary outcome
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).
4 secondary outcomes
Generalized average real variability
Time frame: From intensive card unit admission after surgery to 6 hours post-admission
Vasopressor-free days
Time frame: For up to 14 days post-surgery
Peak increase in serum creatinine
Time frame: From entollment to postoperative day 3
Maximum stage of acute kidney injury
Time frame: From the end of surgery to postoperative day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Volulyte® (6% HES 130/0.4 in balanced solution) and Crystalloid solutions in people with Cardiac Surgery, run by Seoul National University Hospital at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karam Nam, M.D., Ph.D. (+82 2 2072 0643, karamnam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse kidney events (MAKE) (time frame: For up to 7 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.