Endothelial Function After Cardiac Surgery

• Status: Completed
• Trial end date: 2020-02-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether patients receiving human albumin for plasma volume replacement during cardiac surgery have improved postoperative endothelial function compared to patients receiving 6% hydroxyethyl starch solutions. The postoperative endothelial function, measured with peripheral arterial tonometry as reactive hyperemia index (RHI) within 2 hours following surgery, will be compared in cardiac surgical patients randomized to receive human albumin or 6% HES solutions for intraoperative volume replacement. Within two hours of arrival to the ICU peripheral arterial tonometry using EndoPAT will be performed. In a subset of 40 consecutive patients the investigators will perform additional EndoPAT measurements to describe the expected changes that occur in endothelial function during the perioperative period (baseline, early postoperative and 24 hours postoperative) using RHI.

This study will also determine whether human albumin 5% reduces plasma biomarkers of endothelial and glycocalyceal damage by measuring plasma concentrations of syndecan 1 and endocan at baseline (before surgery), and 1 and 24 hours following surgery. Blood samples will be taken on the morning of the surgery, within one hour of arrival to the intensive care unit (ICU), and 24 hours after surgery or within 2 hours before discharge from the ICU (three times altogether). These samples will be used to measure the plasma concentrations of two biomarkers that measure endothelial injury.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Hydroxyethyl Starch Derivatives

Criteria

Inclusion Criteria:

• Age 40 - 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 Raynaud's disease or other disease associated with upper extremity vascular insufficiency,

• Inability to perform EndoPAT exam (inability to lie still for 15 min, or significant finger deformity),

• 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.