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

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ClinicalTrials.gov Identifier: NCT02288494
Recruitment Status : Unknown
Verified November 2014 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Active, not recruiting
First Posted : November 11, 2014
Last Update Posted : November 11, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Hypoalbuminemia Adult ICU Patient Stewart Approach for Acid Base Disorders Human Albumin Perfusion Other: stewart approach

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Cross-Sectional
Official Title: Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach
Study Start Date : October 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients with severe hypoalbuminemia
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • albumin allergy
  • pregnancy
  • congestive heart failure
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288494


Locations
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France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Julien PASCAL University Hospital, Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02288494    
Other Study ID Numbers: CHU-0204
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: November 11, 2014
Last Verified: November 2014
Keywords provided by University Hospital, Clermont-Ferrand:
hypoalbuminemia
-acid base balance
acid base disorders
 critical ill
Stewart approach
human albumin infusion
Additional relevant MeSH terms:
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Hypoalbuminemia
Hypoproteinemia
Blood Protein Disorders
Hematologic Diseases