Clinical trial NCT02755155: Optimization of Therapeutic Human Serum Albumin Infusion in Selected Critically Ill Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Shock
Systemic Inflammatory Response Syndrome (SIRS)
Hypoalbuminaemia
Keywords: acute circulatory failure requiring norepinephrine
SIRS
Albumin, therapeutic
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 28 days after inclusion between the two groups
Secondary outcomes:
measure: The length of the circulatory failure requiring albumin infusion
timeFrame: The estimated period of time will be from date of baseline visit until the date of discharge from the hospital or date of death from any cause, whichever came first, assessed up to 28 days
Other outcomes:
measure: Daily SOFA score
timeFrame: The outcome measure will be assessed from date of baseline visit until the date of discharge from the hospital or date of death from any cause, whichever came first, assessed up to 28 days
measure: The number of infections in intensive care
timeFrame: Number of care-related infection within intensive care (28 days) unit between the two groups.
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaire de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Francis SCHNEIDER, Prof
role: PRINCIPAL_INVESTIGATOR
References: