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too many patients were expected and the investigative team would not be able to recruit this number
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Primary purpose : mortality at Day 28
Secondary purposes :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous low dosage (CLD) | Experimental | 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) |
|
| Intermittent high dosage (IHD) | Active Comparator | 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% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human serum albumin infusion 4% | Drug | Continuous infusion of 15mL/kg of bodyweight over 24h/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 28 days after inclusion between the two groups |
| Measure | Description | Time Frame |
|---|---|---|
| The length of the circulatory failure requiring albumin infusion | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Daily SOFA score | Daily SOFA score decrease from albumin infusion starting to norepinephrine weaning at least by 30% of its peak dose between the two groups | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis SCHNEIDER, Prof | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaire de Strasbourg | Strasbourg | 67091 | France |
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| Human serum albumin infusion 20% | Drug | 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 |
|
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| The number of infections in intensive care |
The outcome will be assessed with the adverse event notification |
| Number of care-related infection within intensive care (28 days) unit between the two groups. |
| ID | Term |
|---|---|
| D012769 | Shock |
| D018746 | Systemic Inflammatory Response Syndrome |
| D034141 | Hypoalbuminemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007249 | Inflammation |
| D007019 | Hypoproteinemia |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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