Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-25 @ 4:03 AM
NCT ID:
NCT02192502
Eligibility Criteria:
Inclusion Criteria:
* Age 50 - 85 years old
* Scheduled for elective aortic valve replacement with or without coronary artery bypass grafting with or without additional minor surgical procedure.
* Written, informed consent for participation in this investigation.
Exclusion Criteria:
* Patients with renal failure with oliguria or anuria not related to hypovolemia.
* Patients receiving dialysis.
* Patients with preoperative renal insufficiency (Creatinine \> 1.6 mg/dL)
* Anticipated deep hypothermic circulatory arrest
* Known hypersensitivity or allergy to hydroxyethyl starch or the excipients of hydroxyethyl starch
* Clinical conditions with volume overload (e.g., patients in pulmonary edema or congestive heart failure)
* Patients with severe hypernatremia or severe hyperchloremia
* Patients with intracranial bleeding
* Pregnant or breast feeding women
* Critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy, (e.g. patients who are hospitalized in the intensive care unit prior to surgery)
* Severe liver disease
* Pre-existing coagulation or bleeding disorders
* Any contraindications to proposed interventions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT02192502
Study Brief:
Protocol Section:
NCT02192502