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More info
You can access this
clinical trial
if you have
Endothelial Dysfunction
and you are
between 40 and 85
years old
-
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Drug: Human albumin
  • Drug: Hydroxyethyl starch
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Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02882074. The sponsor of the trial is The Cleveland Clinic and it is looking for 85 volunteers for the current phase.
Official trial title:
Does Plasma Volume Replacement With 5% Human Albumin Reduce Endothelial Injury and Glycocalyceal Disruption Compared With 6% Hydroxyethylstarch (130/0.4) in Patients Having Cardiac Surgery? A Substudy of the SHARP Clinical Trial