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

University Hospital, Strasbourg, France

Status and phase: Terminated; Phase 4

Conditions: Shock; Systemic Inflammatory Response Syndrome (SIRS); Hypoalbuminaemia

Treatments: Drug: Human serum albumin infusion 20%; Drug: Human serum albumin infusion 4%

Study type: Interventional

Funder types: Other

Identifiers

NCT02755155

6371

Details and patient eligibility

About

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

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• circulatory failure requiring norepinephrine support (any dose)
• hospitalization within an Intensive Care Unit
• SIRS
• low plasma albumin (< 20g/L)
• consent to study

Exclusion criteria

• absence of circulatory failure
• absence of SIRS
• chronic low albumin concentration
• absence of consent to study
• inability to tolerate human serum albumin
• Patients under guardianship or curators
• Women pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Continuous low dosage (CLD)

Experimental group

Description:

The subjects will received human serum albumin infusion 4%.CLD patients are infused with15ml/kg/day of 4% human serum albumin from inclusion to the day norepinephrine infusion is weaned by 30% (provided their plasma albumin stays in the range 30+3g/L)

Treatment:

Drug: Human serum albumin infusion 4%

Intermittent high dosage (IHD)

Active Comparator group

Description:

The subjects will received human serum albumin infusion 20%.IHD patients are infused with 20% human serum albumin (up to 600 ml/day) until the plasma albumin concentration is in the range 30+3g/L from inclusion to the day norepinephrine infusion is weaned by 30%

Treatment:

Drug: Human serum albumin infusion 20%