Hypoalbuminaemia, Shock, Systemic Inflammatory Response Syndrome (SIRS)
Conditions
Keywords
acute circulatory failure requiring norepinephrine, SIRS, Albumin, therapeutic
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.
Interventions
DRUGHuman serum albumin infusion 4%
Continuous infusion of 15mL/kg of bodyweight over 24h/day
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
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | 28 days after inclusion between the two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The length of the circulatory failure requiring albumin infusion | 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 | Time from albumin infusion starting to the moment when norepinephrine can be weaned at least by 30% of its peak dose with respect of initial mean arterial pressure target between the two groups. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Daily SOFA score | 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 | Daily SOFA score decrease from albumin infusion starting to norepinephrine weaning at least by 30% of its peak dose between the two groups |
| The number of infections in intensive care | Number of care-related infection within intensive care (28 days) unit between the two groups. | The outcome will be assessed with the adverse event notification |
Countries
France
Outcome results
None listed