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

Shock Clinical Trial

— AlbAlsace  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02755155
• Other study ID #: 6371
• Status: Terminated
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: August 10, 2019

Study information

• Verified date: September 2021
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 138
• Est. completion date: August 10, 2019
• Est. primary completion date: August 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Human serum albumin infusion 4%
Continuous infusion of 15mL/kg of bodyweight over 24h/day
• 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

Locations

Country	Name	City	State
France	Hôpitaux Universitaire de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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.
Primary	Mortality		28 days after inclusion between the two groups
Secondary	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