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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

Tracking Information
First Submitted Date September 12, 2014
First Posted Date November 11, 2014
Last Update Posted Date November 11, 2014
Study Start Date October 2013
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 7, 2014)
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. ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 7, 2014)
  • changes in neurologic parameters [ Time Frame: 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. ]
  • changes in respiratory parameters [ Time Frame: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach
Official Title Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach
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.
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
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population ICU patients with severe hypoalbuminemia
Condition
  • Hypoalbuminemia
  • Adult ICU Patient
  • Stewart Approach for Acid Base Disorders
  • Human Albumin Perfusion
Intervention 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.
Study Groups/Cohorts 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
Intervention: Other: stewart approach
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 7, 2014)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2014
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • albumin allergy
  • pregnancy
  • congestive heart failure
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02288494
Other Study ID Numbers CHU-0204
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party University Hospital, Clermont-Ferrand
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Clermont-Ferrand
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Julien PASCAL University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date November 2014