Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications

Phase 4Not Yet RecruitingNCT07410988

Seoul National University Hospital1,292 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

1,292

Conditions

Cardiac Surgery

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.

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).

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (4)

Chungnam National University Hospital

Daejeon, South Korea

Korea University Guro Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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).

Time frame: For up to 7 days post-surgery

Secondary Outcomes

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.

Time frame: 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, or norepinephrine)

Time frame: From intensive care unit admission after surgery to postoperative day 14

Peak increase in serum creatinine

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

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

Central Contacts

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

CONTACT

+82 2 2072 0643 karamnam@gmail.com

Data from ClinicalTrials.gov

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