HypoalbuminemiaSTEWALBNCT02288494
Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach
An observational study of Hypoalbuminemia and Adult ICU Patient, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoalbuminemia, Adult ICU Patient, Stewart Approach for Acid Base Disorders
- What is being tested?
- stewart approach
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patients with severe hypoalbuminemia
Who may be able to join
- serum albuminemia < 20g/L
- adult ICU patient
- Arterial line
Who cannot join
- albumin allergy
- pregnancy
- congestive heart failure
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypoalbuminemia, Adult ICU Patient, Stewart Approach for Acid Base Disorders, Human Albumin Perfusion
- Being tested
- stewart approach
- Keywords
- hypoalbuminemia, -acid base balance, acid base disorders, critical ill, Stewart approach, human albumin infusion
- Medical subject headings
- Hypoalbuminemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stewart approachOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: stewart approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in pH and independent pH determinants using Stewart approach
Measured: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
Secondary outcomes (3)
changes in neurologic parameters
Measured: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
changes in hemodynamic parameters
Measured: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
changes in respiratory parameters
Measured: at 1 hour, 2 hours and 24 hours after a 200mL of 20% human albumin perfusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startOct 2013
- Primary completionNov 2014 (estimated)
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoalbuminemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien PASCAL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288494
- Sponsor's protocol ID
- CHU-0204
- Acronym
- STEWALB
- Status last verified
- Nov 2014
- First submitted
- 12 Sep 2014
- Last updated
- 11 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach
- ClinicalTrials.gov ID
- NCT02288494
- Acronym / sponsor ID
- STEWALB / CHU-0204
- Conditions
- Hypoalbuminemia, Adult ICU Patient, Stewart Approach for Acid Base Disorders, Human Albumin Perfusion
- Keywords
- hypoalbuminemia, -acid base balance, acid base disorders, critical ill, Stewart approach, human albumin infusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypoalbuminemia | – | Other: stewart approachThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients with severe hypoalbuminemia
Key inclusion criteria (3 listed)
- serum albuminemia < 20g/L
- adult ICU patient
- Arterial line
Key exclusion criteria (3 listed)
- albumin allergy
- pregnancy
- congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stewart approachProspective 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. | Other | hypoalbuminemia |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien PASCAL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoalbuminemia and Adult ICU Patient, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2014.