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Comparison of 2 Strategies of Therapeutic Human Serum Albumin Infusion in Critically Ill Patients With Severe Systemic Inflammatory Response Syndrome and Low Plasma Albumin: Continuous Low Versus Intermittent High Doses
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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hôpitaux Universitaire de Strasbourg
Strasbourg, France
Start Date
September 1, 2016
Primary Completion Date
August 10, 2019
Completion Date
August 10, 2019
Last Updated
September 20, 2021
138
ACTUAL participants
Human serum albumin infusion 4%
DRUG
Human serum albumin infusion 20%
DRUG
Lead Sponsor
University Hospital, Strasbourg, France
NCT04419480
NCT07179276
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