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

NCT02755155 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2021-09-20

No results posted yet for this study

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

Interventions

DRUG

Human serum albumin infusion 4%

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

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

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Francis SCHNEIDER, Prof · Hôpitaux Universitaires de Strasbourg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-08-10
Completion
2019-08-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02755155 on ClinicalTrials.gov