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

Hypoalbuminemia Clinical Trial

— STEWALB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02288494
• Other study ID #: CHU-0204
• Status: Active, not recruiting
• Phase: N/A
• First received: September 12, 2014
• Last updated: November 7, 2014
• Start date: October 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• serum albuminemia < 20g/L

• adult ICU patient

• Arterial line

Exclusion Criteria:

• albumin allergy

• pregnancy

• congestive heart failure

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Adult ICU Patient
• Human Albumin Perfusion
• Hypoalbuminemia
• Stewart Approach for Acid Base Disorders

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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in pH and independent pH determinants using Stewart approach		at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.	No
Secondary	changes in neurologic parameters		at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.	No
Secondary	changes in hemodynamic parameters		at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.	No
Secondary	changes in respiratory parameters		at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.	No