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Clinical Trial Summary

Primary purpose : mortality at Day 28 Secondary purposes : - Daily SOFA (Sequential Organ Failure Assessment) score lessening within Intensive Care Unit (ICU) - Duration of increasing doses of norepinephrine infusion to maintain target mean arterial pressure - Number of care-related infections within ICU


Clinical Trial Description

According to currently available literature on therapeutic albumin infusion in critically ill patients, there is room for new approaches to delineate an optimal use of this expansive treatment. Indeed, many authors suggest that the present clinical use of albumin is questionable in critically ill patients as far as changes in morbidity or mortality are concerned and with regards to cost-effectiveness. It has been reported that protein misfolding and aggregation are a hallmark of several inflammatory diseases. In vitro studies show that very small amounts of albumin are able to restore the physiologic activities of endogenous circulating proteins that had been aggregated in multimeric form during oxidative stress. Recently, the investigators have reported that in vitro albumin restores antimicrobial and anti-inflammatory effects of some chromogranin A-derived peptides. The investigators therefore search to test in vivo, in critically ill patients with severe systemic inflammation requiring norepinephrine infusion, whether therapeutic albumin infused at a low and continuous dosage may modify mortality (primary purpose) and morbidity (secondary purposes) in comparison with intermittent high dosage albumin infusion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02755155
Study type Interventional
Source University Hospital, Strasbourg, France
Contact
Status Terminated
Phase Phase 4
Start date September 2016
Completion date August 10, 2019

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