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

Phase 4TerminatedNCT02755155

University Hospital, Strasbourg, France138 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

138

Conditions

Shock Systemic Inflammatory Response Syndrome (SIRS)Hypoalbuminaemia

Interventions

Human serum albumin infusion 4%DRUG

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

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpitaux Universitaire de Strasbourg

Strasbourg, France

Outcomes

Primary Outcomes

Mortality

Time frame: 28 days after inclusion between the two groups

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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