Optimization of Therapeutic Human Serum Albumin Infusion in Selected Critically Ill Patients — AlbAlsace  

Shock Clinical Trial

Official title: 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

Status Terminated

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. ;

Related Conditions & MeSH terms

• Hypoalbuminaemia
• Hypoalbuminemia
• Shock
• Syndrome
• Systemic Inflammatory Response Syndrome
• Systemic Inflammatory Response Syndrome (SIRS)

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