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

NCT02755155 | Terminated Phase 4

• 1 other identifier: 6371
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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

Conditions

Shock; Systemic Inflammatory Response Syndrome (SIRS); Hypoalbuminaemia

Keywords

acute circulatory failure requiring norepinephrine; SIRS; Albumin, therapeutic

Outcome Measures

Primary Outcomes (1)

• Mortality

  28 days after inclusion between the two groups

Secondary Outcomes (1)

• The length of the circulatory failure requiring albumin infusion

  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 Outcomes (2)

• Daily SOFA score

  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

  Number of care-related infection within intensive care (28 days) unit between the two groups.

Study Arms (2)

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)

Drug: Human serum albumin infusion 4%

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%

Drug: Human serum albumin infusion 20%

Interventions

Human serum albumin infusion 4% DRUG

Continuous infusion of 15mL/kg of bodyweight over 24h/day

Also known as: VIALEBEX* 4%

Continuous low dosage (CLD)

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

Also known as: VIALEBEX* 20%

Intermittent high dosage (IHD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• circulatory failure requiring norepinephrine support (any dose)
• hospitalization within an Intensive Care Unit
• SIRS
• low plasma albumin (\< 20g/L)
• consent to study

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Shock; Systemic Inflammatory Response Syndrome; Hypoalbuminemia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Francis SCHNEIDER, Prof

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 28, 2016
• Study Start: September 1, 2016
• Primary Completion: August 10, 2019
• Study Completion: August 10, 2019
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)