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Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications

NCT07410988 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1292

Last updated 2026-05-19

No results posted yet for this study

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

Interventions

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.

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).

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-03-31
Completion
2029-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07410988 on ClinicalTrials.gov