Endothelial Function After Cardiac Surgery

NCT02882074 | Completed Results

• 1 other identifier: 16-342
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Reactive Hyperemia Index (RHI)

  RHI measures endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT) with the EndoPAT device. It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post-to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered a sign of endothelial dysfunction and RHI equal to or greater than 1.67 is considered normal function. Increasing score indicates the improvement of coronary endothelial function.

  2 hours after surgery

Secondary Outcomes (2)

• Plasma Concentrations of Syndecan

  1 hour after surgery, 24 hours after surgery

• Plasma Concentrations of Endocan

  1 hour after surgery, 24 hours after surgery

Other Outcomes (1)

• Reactive Hyperemia Index (RHI)

  24 hours after surgery

Study Arms (2)

Human albumin

OTHER

Human albumin 5% during surgery.

Drug: Human albumin

Hydroxyethyl starch

OTHER

Hydroxyethyl starch 6% (130/0.4) solution during surgery

Drug: Hydroxyethyl starch

Interventions

Human albumin DRUG

human albumin 5% during surgery

Also known as: albumin

Human albumin

Hydroxyethyl starch DRUG

6% Hydroxyethyl starch 130/0.4 during surgery

Also known as: HES

Hydroxyethyl starch

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Serum Albumin, Human; Albumins; Hydroxyethyl Starch Derivatives

Intervention Hierarchy (Ancestors)

Serum Albumin; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins; Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Results Point of Contact

• Title: Dr. Marta Kelava
• Organization: Cleveland Clinic

kelavam@ccf.org

2162133218

Study Officials

• Daniel Sessler, M.D.

  Department Chair

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 29, 2016
• Study Start: June 1, 2016
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)