Status:
COMPLETED
Use of 6% Hydroxyethylstarch (130/0.4) in Cardiac Surgical Patients
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
Fresenius Kabi
Conditions:
Postoperative Kidney Injury
Eligibility:
All Genders
40-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety of a standard volume replacement called HES 130/0.4 (Voluven) during surgery on recovery. HES 130/0.4 (Voluven) may offer an alternative to pure flu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2020
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT02192502
Start Date
March 1 2015
End Date
February 1 2020
Last Update
February 14 2023
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195