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

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

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

Study Overview

• Status: Terminated
• Conditions: Shock; Systemic Inflammatory Response Syndrome (SIRS); Hypoalbuminaemia
• Intervention / Treatment: Drug: Human serum albumin infusion 4%; Drug: Human serum albumin infusion 20%

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 Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67091
    • Hopitaux Universitaire de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: VIALEBEX* 20%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	28 days after inclusion between the two groups

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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
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.

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Francis SCHNEIDER, Prof, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): August 10, 2019
• Study Completion (Actual): August 10, 2019

Study Registration Dates

• First Submitted: April 13, 2016
• First Submitted That Met QC Criteria: April 25, 2016
• First Posted (Estimate): April 28, 2016

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: SIRS; acute circulatory failure requiring norepinephrine; Albumin, therapeutic
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Disease; Hematologic Diseases; Blood Protein Disorders; Shock; Hypoproteinemia; Syndrome; Systemic Inflammatory Response Syndrome; Hypoalbuminemia
• Other Study ID Numbers: 6371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No