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NCT02882074 · ClinicalTrials.gov registry record · NA
Endothelial Function After Cardiac Surgery
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 85
- Enrollment target
NCT02882074 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 85 participants.
The verdict
NCT02882074, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 85 participants
- Enrollment target
Study 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.
Interventions
- DRUG Human albumin
- DRUG Hydroxyethyl starch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2016-06 |
| Est. Completion | 2020-02-20 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02882074
The ClinicalTrials.gov registry entry for NCT02882074 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Human albumin is the first listed.
NCT02882074 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02882074 about?
NCT02882074 is a clinical study titled "Endothelial Function After Cardiac Surgery". 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 wi...
What is the current status of trial NCT02882074?
This trial is currently completed. It is a NA study. The enrollment target is 85 participants. The study started on 2016-06. Estimated completion is 2020-02-20.
What interventions are being tested in trial NCT02882074?
The interventions under investigation include: Human albumin (DRUG), Hydroxyethyl starch (DRUG).
Who is sponsoring clinical trial NCT02882074?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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