Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach (STEWALB)

November 7, 2014 updated by: University Hospital, Clermont-Ferrand
The primary purpose was to describe the acid base balance of ICU patients with severe hypoalbuminemia using Stewart's approach for acid base disorders, before and after an human albumin perfusion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Prospective study, for ICU patient with severe hypoalbuminemia < 20g/L, determining biological parameters from Stewart approach for acid base disorders (pH, SIDe, SIDa, SIG, Atot, PaCO2) before, and at 1hour, 2hours and 24 hours after a 200mL 20% human albumin perfusion (the consensus conference ANAES of 1995 recommands to correct hypoalbuminemia below 20g/L).

Clinical parameters (respiratory, haemodynamic, neurologic) were also collected at the same times.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICU patients with severe hypoalbuminemia

Description

Inclusion Criteria:

  • serum albuminemia < 20g/L
  • adult ICU patient
  • Arterial line

Exclusion Criteria:

  • albumin allergy
  • pregnancy
  • congestive heart failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hypoalbuminemia
The primary purpose was to describe the acid base balance of ICU patients with severe hypoalbuminemia using Stewart's approach for acid base disorders, before and after an human albumin perfusion
Other: stewart approach
Prospective study, for ICU patient with severe hypoalbuminemia < 20g/L, determining biological parameters from Stewart approach for acid base disorders (pH, SIDe, SIDa, SIG, Atot, PaCO2) before, and at 1hour, 2hours and 24 hours after a 200mL 20% human al Clinical parameters (respiratory, haemodynamic, neurologic) were also collected at the same times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in pH and independent pH determinants using Stewart approach
Time Frame: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in neurologic parameters
Time Frame: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
changes in hemodynamic parameters
Time Frame: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
changes in respiratory parameters
Time Frame: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Julien PASCAL, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Estimate)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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