Septic ShockTOADSNCT02547467
TOADS Study: TO Assess Death From Septic Shock.
An observational study of Septic Shock, run by University Hospital, Angers.
Trial summary
The aim of this study is to assess the causes of death in patients with septic shock in French intensive care units. It is an epidemiologic and descriptive study . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- epidemiologic study
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to May 2016
- 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: Consecutive patients who had died of septic shock
Who may be able to join
- Adult patient
- Died of septic shock in the intensive care unit (ICU)
- At least 6 hours of vasopressors
Who cannot join
- Legally protected adult patient.
- Less than 6 hours of vasopressors
- Opposition to participation in the study expressed by the patient, family or person of trust
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Epidemiological Survey of Death Modalities in Patients With Septic Shock Referred to French Intensive Care Units: TOADS Study.
The aim of this study is to assess the causes of death in patients with septic shock in French intensive care units. It is an epidemiologic and descriptive study .
Read the detailed description
The purpose of this epidemiologic study is to describe with accuracy the reasons and causes of death in patients with septic shock during patients stay in intensive care units. All deceased patients with primary diagnosis of septic shock will be included in this survey and patients baseline characteristics as well as the clinical and data at the time of patient's death will be recorded.
- Conditions
- Septic Shock
- Being tested
- epidemiologic study
- Keywords
- mortality
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidemiologic studyOther
There is no intervention as it is a pure observational study for epidemiologic survey.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this study is to identify the reasons of death of patients with septic shock via a questionnaire.
Recording of the context and the cause of death with a questionnaire
Measured: Patients will be followed during their hospital stay, with a maximal follow up of 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
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.
- More trials run by University Hospital, AngersThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Laboratoire français de Fractionnement et de Biotechnologies
- Responsible party
- Sponsor
- Investigators
- Pierre ASFAR, MD-PhD, Study director, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547467
- Sponsor's protocol ID
- 49RC14_0223
- Acronym
- TOADS
- Status last verified
- Sep 2015
- First submitted
- 8 Jul 2015
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Survey of Death Modalities in Patients With Septic Shock Referred to French Intensive Care Units: TOADS Study.
- ClinicalTrials.gov ID
- NCT02547467
- Acronym / sponsor ID
- TOADS / 49RC14_0223
- Conditions
- Septic Shock
- Keywords
- mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Laboratoire français de Fractionnement et de Biotechnologies
- Study start
- Sep 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 11 Sep 2015 (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 aim of this study is to assess the causes of death in patients with septic shock in French intensive care units. It is an epidemiologic and descriptive study .
Detailed description
The purpose of this epidemiologic study is to describe with accuracy the reasons and causes of death in patients with septic shock during patients stay in intensive care units. All deceased patients with primary diagnosis of septic shock will be included in this survey and patients baseline characteristics as well as the clinical and data at the time of patient's death will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who had died of septic shock
Key inclusion criteria (3 listed)
- Adult patient
- Died of septic shock in the intensive care unit (ICU)
- At least 6 hours of vasopressors
Key exclusion criteria (3 listed)
- Legally protected adult patient.
- Less than 6 hours of vasopressors
- Opposition to participation in the study expressed by the patient, family or person of trust
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 |
|---|---|---|
| epidemiologic studyThere is no intervention as it is a pure observational study for epidemiologic survey. | Other | – |
Primary outcome
The primary outcome of this study is to identify the reasons of death of patients with septic shock via a questionnaire.
Time frame: Patients will be followed during their hospital stay, with a maximal follow up of 90 days
Recording of the context and the cause of death with a questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2015.
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Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
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Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
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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.
Pierre ASFAR, MD-PhD study director
University Hospital, Angers
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by University Hospital, Angers.
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 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Pierre ASFAR, MD-PhD (+33(0)241353815, piasfar@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of this study is to identify the reasons of death of patients with septic shock via a questionnaire. (time frame: Patients will be followed during their hospital stay, with a maximal follow up of 90 days). 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 Sep 2015.