NCT02755155

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Human serum albumin infusion 4%	Continuous infusion of 15mL/kg of bodyweight over 24h/day
DRUG	Human serum albumin infusion 20%	Specify details not covered in associated Arm Description. Intermittent infusion up to 200 ml/8h/day until the plasma albumin concentration is in the range 30+3g/L

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-08-10
• Completion: 2019-08-10
• First posted: 2016-04-28
• Last updated: 2021-09-20

Locations

1 site across 1 country: France