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

Primary Purpose

Shock, Systemic Inflammatory Response Syndrome (SIRS), Hypoalbuminaemia

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Human serum albumin infusion 4%
Human serum albumin infusion 20%
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shock focused on measuring acute circulatory failure requiring norepinephrine, SIRS, Albumin, therapeutic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpitaux Universitaire de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Continuous low dosage (CLD)

Intermittent high dosage (IHD)

Arm Description

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)

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%

Outcomes

Primary Outcome Measures

Mortality

Secondary Outcome Measures

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.

Full Information

First Posted
April 13, 2016
Last Updated
September 13, 2021
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02755155
Brief Title
Optimization of Therapeutic Human Serum Albumin Infusion in Selected Critically Ill Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
too many patients were expected and the investigative team would not be able to recruit this number
Study Start Date
September 2016 (Actual)
Primary Completion Date
August 10, 2019 (Actual)
Study Completion Date
August 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shock, Systemic Inflammatory Response Syndrome (SIRS), Hypoalbuminaemia
Keywords
acute circulatory failure requiring norepinephrine, SIRS, Albumin, therapeutic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous low dosage (CLD)
Arm Type
Experimental
Arm Description
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)
Arm Title
Intermittent high dosage (IHD)
Arm Type
Active Comparator
Arm Description
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%
Intervention Type
Drug
Intervention Name(s)
Human serum albumin infusion 4%
Other Intervention Name(s)
VIALEBEX* 4%
Intervention Description
Continuous infusion of 15mL/kg of bodyweight over 24h/day
Intervention Type
Drug
Intervention Name(s)
Human serum albumin infusion 20%
Other Intervention Name(s)
VIALEBEX* 20%
Intervention Description
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
Primary Outcome Measure Information:
Title
Mortality
Time Frame
28 days after inclusion between the two groups
Secondary Outcome Measure Information:
Title
The length of the circulatory failure requiring albumin infusion
Description
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.
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
Other Pre-specified Outcome Measures:
Title
Daily SOFA score
Description
Daily SOFA score decrease from albumin infusion starting to norepinephrine weaning at least by 30% of its peak dose between the two groups
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
Title
The number of infections in intensive care
Description
The outcome will be assessed with the adverse event notification
Time Frame
Number of care-related infection within intensive care (28 days) unit between the two groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis SCHNEIDER, Prof
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaire de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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