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

• Conditions: Stewart Approach for Acid Base Disorders; Adult ICU Patient; Hypoalbuminemia; Human Albumin Perfusion
• Interventions: Other: stewart approach

• Registration Number: NCT02288494
• Lead Sponsor: University Hospital, Clermont-Ferrand

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-09-12
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted QC: 2014-11-07
• Last Update Submitted: 2014-11-07
• Study First Posted: 2014-11-11
• Last Update Posted: 2014-11-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

• albumin allergy
• pregnancy
• congestive heart failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hypoalbuminemia	stewart approach	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

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France