ShockPhase 4AlbAlsaceNCT02755155
Optimization of Therapeutic Human Serum Albumin Infusion in Selected Critically Ill Patients
A Phase 4 study testing Human serum albumin infusion 4% and Human serum albumin infusion 20% in people with Shock and Systemic Inflammatory Response Syndrome (SIRS), run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Primary purpose : mortality at Day 28 Secondary purposes : Daily SOFA (Sequential Organ Failure Assessment) score lessening within Intensive Care Unit (ICU) Duration of increasing doses of norepinephrine infusion to maintain target mean arterial pressure Number of care-related infections within ICU Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Systemic Inflammatory Response Syndrome (SIRS), Hypoalbuminaemia
- What is being tested?
- Human serum albumin infusion 4% and Human serum albumin infusion 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to 10 Aug 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- circulatory failure requiring norepinephrine support (any dose)
- hospitalization within an Intensive Care Unit
- SIRS
- low plasma albumin (< 20g/L)
- consent to study
Who cannot join
- absence of circulatory failure
- absence of SIRS
- chronic low albumin concentration
- absence of consent to study
- inability to tolerate human serum albumin
- Patients under guardianship or curators
- Women pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 2 Strategies of Therapeutic Human Serum Albumin Infusion in Critically Ill Patients With Severe Systemic Inflammatory Response Syndrome and Low Plasma Albumin: Continuous Low Versus Intermittent High Doses
Primary purpose : mortality at Day 28
Secondary purposes :
- Daily SOFA (Sequential Organ Failure Assessment) score lessening within Intensive Care Unit (ICU)
- Duration of increasing doses of norepinephrine infusion to maintain target mean arterial pressure
- Number of care-related infections within ICU
Read the detailed description
According to currently available literature on therapeutic albumin infusion in critically ill patients, there is room for new approaches to delineate an optimal use of this expansive treatment. Indeed, many authors suggest that the present clinical use of albumin is questionable in critically ill patients as far as changes in morbidity or mortality are concerned and with regards to cost-effectiveness.
It has been reported that protein misfolding and aggregation are a hallmark of several inflammatory diseases. In vitro studies show that very small amounts of albumin are able to restore the physiologic activities of endogenous circulating proteins that had been aggregated in multimeric form during oxidative stress. Recently, the investigators have reported that in vitro albumin restores antimicrobial and anti-inflammatory effects of some chromogranin A-derived peptides. The investigators therefore search to test in vivo, in critically ill patients with severe systemic inflammation requiring norepinephrine infusion, whether therapeutic albumin infused at a low and continuous dosage may modify mortality (primary purpose) and morbidity (secondary purposes) in comparison with intermittent high dosage albumin infusion.
- Being tested
- Human serum albumin infusion 4%, Human serum albumin infusion 20%
- Keywords
- acute circulatory failure requiring norepinephrine, SIRS, Albumin, therapeutic
- Medical subject headings
- Shock, Systemic Inflammatory Response Syndrome, Hypoalbuminemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human serum albumin infusion 4%Drug
Also called VIALEBEX* 4%
Continuous infusion of 15mL/kg of bodyweight over 24h/day
Human serum albumin infusion 20%Drug
Also called VIALEBEX* 20%
Specify details not covered in associated Arm Description. Intermittent infusion up to 200 ml/8h/day until the plasma albumin concentration is in the range 30+3g/L
| Study group | Role | What they receive |
|---|---|---|
| Continuous low dosage (CLD) | Experimental | The subjects will received human serum albumin infusion 4%.CLD patients are infused with15ml/kg/day of 4% human serum albumin from inclusion to the day norepinephrine infusion is weaned by 30% (provided their plasma albumin stays in the range 30+3g/L) Receives: Drug: Human serum albumin infusion 4% |
| Intermittent high dosage (IHD) | Active comparator | The subjects will received human serum albumin infusion 20%.IHD patients are infused with 20% human serum albumin (up to 600 ml/day) until the plasma albumin concentration is in the range 30+3g/L from inclusion to the day norepinephrine infusion is weaned by 30% Receives: Drug: Human serum albumin infusion 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 28 days after inclusion between the two groups
Secondary outcomes (1)
The length of the circulatory failure requiring albumin infusion
Time from albumin infusion starting to the moment when norepinephrine can be weaned at least by 30% of its peak dose with respect of initial mean arterial pressure target between the two groups.
Measured: The estimated period of time will be from date of baseline visit until the date of discharge from the hospital or date of death from any cause, whichever came first, assessed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startSep 2016
- Primary completion10 Aug 2019
- Study completion10 Aug 2019
Why it stopped: too many patients were expected and the investigative team would not be able to recruit this number
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis SCHNEIDER, Prof, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755155
- Sponsor's protocol ID
- 6371
- Acronym
- AlbAlsace
- Status last verified
- Sep 2021
- First submitted
- 13 Apr 2016
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2 Strategies of Therapeutic Human Serum Albumin Infusion in Critically Ill Patients With Severe Systemic Inflammatory Response Syndrome and Low Plasma Albumin: Continuous Low Versus Intermittent High Doses
- ClinicalTrials.gov ID
- NCT02755155
- Acronym / sponsor ID
- AlbAlsace / 6371
- Keywords
- acute circulatory failure requiring norepinephrine, SIRS, Albumin, therapeutic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: too many patients were expected and the investigative team would not be able to recruit this number
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 10 Aug 2019 (actual)
- Study completion
- 10 Aug 2019 (actual)
- First posted
- 28 Apr 2016 (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.
Primary purpose : mortality at Day 28
Secondary purposes :
- Daily SOFA (Sequential Organ Failure Assessment) score lessening within Intensive Care Unit (ICU)
- Duration of increasing doses of norepinephrine infusion to maintain target mean arterial pressure
- Number of care-related infections within ICU
Detailed description
According to currently available literature on therapeutic albumin infusion in critically ill patients, there is room for new approaches to delineate an optimal use of this expansive treatment. Indeed, many authors suggest that the present clinical use of albumin is questionable in critically ill patients as far as changes in morbidity or mortality are concerned and with regards to cost-effectiveness.
It has been reported that protein misfolding and aggregation are a hallmark of several inflammatory diseases. In vitro studies show that very small amounts of albumin are able to restore the physiologic activities of endogenous circulating proteins that had been aggregated in multimeric form during oxidative stress. Recently, the investigators have reported that in vitro albumin restores antimicrobial and anti-inflammatory effects of some chromogranin A-derived peptides. The investigators therefore search to test in vivo, in critically ill patients with severe systemic inflammation requiring norepinephrine infusion, whether therapeutic albumin infused at a low and continuous dosage may modify mortality (primary purpose) and morbidity (secondary purposes) in comparison with intermittent high dosage albumin infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous low dosage (CLD) | Experimental | Drug: Human serum albumin infusion 4%The subjects will received human serum albumin infusion 4%.CLD patients are infused with15ml/kg/day of 4% human serum albumin from inclusion to the day norepinephrine infusion is weaned by 30% (provided their plasma albumin stays in the range 30+3g/L) |
| Intermittent high dosage (IHD) | Active comparator | Drug: Human serum albumin infusion 20%The subjects will received human serum albumin infusion 20%.IHD patients are infused with 20% human serum albumin (up to 600 ml/day) until the plasma albumin concentration is in the range 30+3g/L from inclusion to the day norepinephrine infusion is weaned by 30% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- circulatory failure requiring norepinephrine support (any dose)
- hospitalization within an Intensive Care Unit
- SIRS
- low plasma albumin (< 20g/L)
- consent to study
Key exclusion criteria (7 listed)
- absence of circulatory failure
- absence of SIRS
- chronic low albumin concentration
- absence of consent to study
- inability to tolerate human serum albumin
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 |
|---|---|---|
| Human serum albumin infusion 4%Also: VIALEBEX* 4%Continuous infusion of 15mL/kg of bodyweight over 24h/day | Drug | Continuous low dosage (CLD) |
| Human serum albumin infusion 20%Also: VIALEBEX* 20%Specify details not covered in associated Arm Description. Intermittent infusion up to 200 ml/8h/day until the plasma albumin concentration is in the range 30+3g/L | Drug | Intermittent high dosage (IHD) |
Primary outcome
Mortality
Time frame: 28 days after inclusion between the two groups
1 secondary outcome
The length of the circulatory failure requiring albumin infusion
Time frame: The estimated period of time will be from date of baseline visit until the date of discharge from the hospital or date of death from any cause, whichever came first, assessed up to 28 days
Results and safety
The study was stopped early (reason given: too many patients were expected and the investigative team would not be able to recruit this number). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Francis SCHNEIDER, Prof principal investigator
Hôpitaux Universitaires de Strasbourg
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 Human serum albumin infusion 4% and Human serum albumin infusion 20% in people with Shock and Systemic Inflammatory Response Syndrome (SIRS), run by University Hospital, Strasbourg, France 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 20 Sep 2021. 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.
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 was stopped early (reason given: too many patients were expected and the investigative team would not be able to recruit this number). 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?
Mortality (time frame: 28 days after inclusion between the two groups). 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 20 Sep 2021.