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Compares treatment options for Cardiac Surgery
Official title Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications
ClinicalTrials.gov ID: NCT07410988
What this study is testing
What is Volulyte® (6% HES 130/0.4 in balanced solution)?
Volulyte® (6% HES 130/0.4 in balanced solution) is an investigational medicine, being studied as a potential treatment for cardiac surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Patients aged 19 years or older scheduled for coronary artery bypass grafting (CABG), heart valve surgery, and/or thoracic aortic surgery
You likely can't join 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;
See the full eligibility criteria
- Patients aged 19 years or older scheduled for coronary artery bypass grafting (CABG), heart valve surgery, and/or thoracic aortic surgery
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Daejeon, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Daejeon, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.