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

NCT ID: NCT02755155

Last Updated: 2021-09-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-08-10

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.

Conditions

Shock; Systemic Inflammatory Response Syndrome (SIRS); Hypoalbuminaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Human serum albumin infusion 4%

Intervention Type: DRUG

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

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%

Group Type: ACTIVE_COMPARATOR

Human serum albumin infusion 20%

Intervention Type: 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

Interventions

Human serum albumin infusion 4%

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

VIALEBEX* 4%; VIALEBEX* 20%

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis SCHNEIDER, Prof

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Hôpitaux Universitaire de Strasbourg

Strasbourg, , France

Countries

France

Other Identifiers

6371

Identifier Type: -

Identifier Source: org_study_id