Septic ShockPhase 4NCT00327704
Early Albumin Resuscitation During Septic Shock
A Phase 4 study testing albumin and saline in people with Septic Shock, run by Laboratoire français de Fractionnement et de Biotechnologies at 1 site in France.
Trial summary
Objective: To determine whether the early administration of albumin as an expander and antioxidant would improve survival on the 28th day for septic shock patients. Design: Prospective, multicenter, randomized, controlled versus saline, stratified on nosocomial infection and center. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- albumin and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 794 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2006to Jan 2011
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- Septic shock < 6 hours
- Agreement of patients
Who cannot join
- Allergy to albumin
- Weight > 120 kg
- Non septic shock
- Burned
- Cirrhosis
- Albumin perfusion 48 hours before randomization
Show all 9Show fewer
- Pregnant women
- Cardiac dysfunction New York Heart Association (NYHA) 3 or 4
- Patients with therapeutic limitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline
Objective: To determine whether the early administration of albumin as an expander and antioxidant would improve survival on the 28th day for septic shock patients.
Design: Prospective, multicenter, randomized, controlled versus saline, stratified on nosocomial infection and center.
Setting: 27 Intensive Care Units (ICU) in France
Coordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris
Patients: 800 patients could be included during the first 6 hours of their septic shock.
Read the detailed description
The primary outcome: Mortality during the 28 day period after randomization. The secondary outcomes: Evaluation of SOFA score, ventilator-free days, dialysis free days, catecholamine free days, days of hospitalisation, incidence of nosocomial infections.
The albuminemia of all patients is requested before the treatment until Day 4 post treatment.
The treatment is: Vialebex 20% 100ml every 8 hours during 3 days versus saline 100ml every 8 hours during 3 days.
The first patient will be in July 2006, the last patient expected is on July 2009.
- Conditions
- Septic Shock
- Being tested
- albumin, saline
- Keywords
- Septic Shock
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albuminDrug
Also called Vialebex
albumin 20% 100 ml/8 hours for 3 days
salineDrug
saline 100 ml/8hours for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Albumin | Active comparator | Not described Receives: Drug: albumin |
| Saline | Placebo comparator | Not described Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality, any cause, during the 28 day period after randomization
Measured: day 28
Secondary outcomes (6)
Evaluation of sequential organ failure assessment (SOFA) score
Measured: ICU period
catecholamine free days
Measured: day 28
incidence of nosocomial infection
Measured: ICU period
mortality at 90 days
Measured: day 90
length of ICU hospitalisation
Measured: ICU discharge
length of total hospitalisation
Measured: hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 794 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean P Mira, Professor, Study chair, Cochin HospitalJulien Charpentier, Doctor, Study director, Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00327704
- Sponsor's protocol ID
- LFB N°ALBU-0503
- Status last verified
- Apr 2011
- First submitted
- 17 May 2006
- Last updated
- 6 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Randomized, Controlled Open Study Albumin 20% Versus Saline
- ClinicalTrials.gov ID
- NCT00327704
- Acronym / sponsor ID
- LFB N°ALBU-0503
- Conditions
- Septic Shock
- Keywords
- Septic Shock
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 794 participants (actual)
- Lead sponsor
- Laboratoire français de Fractionnement et de BiotechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 May 2006 (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.
Objective: To determine whether the early administration of albumin as an expander and antioxidant would improve survival on the 28th day for septic shock patients.
Design: Prospective, multicenter, randomized, controlled versus saline, stratified on nosocomial infection and center.
Setting: 27 Intensive Care Units (ICU) in France
Coordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris
Patients: 800 patients could be included during the first 6 hours of their septic shock.
Detailed description
The primary outcome: Mortality during the 28 day period after randomization. The secondary outcomes: Evaluation of SOFA score, ventilator-free days, dialysis free days, catecholamine free days, days of hospitalisation, incidence of nosocomial infections.
The albuminemia of all patients is requested before the treatment until Day 4 post treatment.
The treatment is: Vialebex 20% 100ml every 8 hours during 3 days versus saline 100ml every 8 hours during 3 days.
The first patient will be in July 2006, the last patient expected is on July 2009.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin | Active comparator | Drug: albumin |
| Saline | Placebo comparator | Drug: saline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- Septic shock < 6 hours
- Agreement of patients
Key exclusion criteria (9 listed)
- Allergy to albumin
- Weight > 120 kg
- Non septic shock
- Burned
- Cirrhosis
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 |
|---|---|---|
| albuminAlso: Vialebexalbumin 20% 100 ml/8 hours for 3 days | Drug | Albumin |
| salinesaline 100 ml/8hours for 3 days | Drug | Saline |
Primary outcome
Mortality, any cause, during the 28 day period after randomization
Time frame: day 28
6 secondary outcomes
Evaluation of sequential organ failure assessment (SOFA) score
Time frame: ICU period
catecholamine free days
Time frame: day 28
incidence of nosocomial infection
Time frame: ICU period
mortality at 90 days
Time frame: day 90
length of ICU hospitalisation
Time frame: ICU discharge
length of total hospitalisation
Time frame: hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
Related trials for Septic Shock
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
Jean P Mira, Professor study chair
Cochin Hospital
Julien Charpentier, Doctor study director
Hôpital Cochin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing albumin and saline in people with Septic Shock, run by Laboratoire français de Fractionnement et de Biotechnologies 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 9 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: finished, as of the sponsor's last update on 6 Apr 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality, any cause, during the 28 day period after randomization (time frame: day 28). 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 6 Apr 2011.