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

• ClinicalTrials.gov Identifier: NCT02755155
• Recruitment Status: Terminated
• First Posted: April 28, 2016
• Last Update Posted: September 20, 2021
• Sponsor: University Hospital, Strasbourg, France
• Information provided by (Responsible Party): University Hospital, Strasbourg, France

Study Description

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

Condition or disease	Intervention/treatment	Phase
Shock; Systemic Inflammatory Response Syndrome (SIRS); Hypoalbuminaemia	Drug: Human serum albumin infusion 4%; Drug: Human serum albumin infusion 20%	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 2016
• Actual Primary Completion Date: August 10, 2019
• Actual Study Completion Date: August 10, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Continuous low dosage (CLD); 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)	Drug: Human serum albumin infusion 4%; Continuous infusion of 15mL/kg of bodyweight over 24h/day; Other Name: VIALEBEX* 4%
Active Comparator: Intermittent high dosage (IHD); 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%	Drug: 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; Other Name: VIALEBEX* 20%

Outcome Measures

Primary Outcome Measures :

1. Mortality [ Time Frame: 28 days after inclusion between the two groups ]

Secondary Outcome Measures :

1. The length of the circulatory failure requiring albumin infusion [ Time Frame: 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 Outcome Measures:

1. Daily SOFA score [ Time Frame: 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
2. The number of infections in intensive care [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

France

Hôpitaux Universitaire de Strasbourg

Strasbourg, France, 67091

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

• Principal Investigator: Francis SCHNEIDER, Prof; Hôpitaux Universitaires de Strasbourg

More Information

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT02755155
• Other Study ID Numbers: 6371
• First Posted: April 28, 2016
• Last Update Posted: September 20, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Strasbourg, France:

acute circulatory failure requiring norepinephrine; SIRS; Albumin, therapeutic

Additional relevant MeSH terms:

Hypoalbuminemia; Syndrome; Systemic Inflammatory Response Syndrome; Disease; Pathologic Processes; Inflammation; Shock; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases