Septic ShockSNA&SepsisNCT00835913
Autonomic Nervous System Alteration Induce by Sepsis: Assessment and Prognosis Impact
An observational study of Septic Shock and Severe Sepsis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Severe sepsis and septic shock are causes of admission in intensive care units.Modification of natriuretic peptid including NT-proBNP and cardiac autonomic nervous system alteration are reported in sepsis shock and severe sepsis and seems to link to patient prognosis admitted to intensive care units. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Septic Shock, Severe Sepsis
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Sep 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patient transfer in intensive care unit with sepsis chock or severe sepsis define as Bone criteria.
Who may be able to join
- Patient over 18 years admitted in intensive care unit and having severe sepsis criteria or septic shock documented or suspected define as Bone Criteria
- hemodynamically stable situation
- sinusal rhythm
- Patient for social security
Who cannot join
- Minors
- Patient under guardianship or trusteeship
- pregnant or lactating women
- diabetic
- cardiomyopathy known and/or treated or detect in admission
- electro-systolic process permanent or transitory
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- neurological history or degenerative pathology
- chronic respiratory insufficiency
- Chronic renal insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autonomic Nervous System Alteration Induce by Sepsis:Assessment and Prognosis Impact
Severe sepsis and septic shock are causes of admission in intensive care units.Modification of natriuretic peptid including NT-proBNP and cardiac autonomic nervous system alteration are reported in sepsis shock and severe sepsis and seems to link to patient prognosis admitted to intensive care units.
Read the detailed description
Our principal aim is to characterize modulation of cardiac sympathic nervous system in sepsis through the study of sinusal change and myocardiac fixing of MIBG.
The second aim is 1)to assess links between alteration of cardiac sympathic nervous system and NT-PRoBNP variations in sepsis and 2)To know prognostic impact in sympathic nervous system compare to NTproBNP.
- Conditions
- Septic Shock, Severe Sepsis
- Keywords
- Autonomic nervous system, Sepsis shock, severe sepsis, sinusal change, Myocardiac fixing, NTproBNP, Patient in intensive care unit with sepsis shock or severe, Sepsis
- Medical subject headings
- Shock, Septic, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinusal variability analysis and myocardic fixation of MIBG performed in 48 hours post admission
Measured: 48 hours post admission
Secondary outcomes (1)
plasmatic measure of NT-ProBNP and catecholamine at admission, day 2 and last day of hospitalisation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionSep 2011
- Study completionSep 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.
- More trials run by University Hospital, GrenobleThe 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SCHWEBEL Carole, PH, Principal investigator, Unit intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835913
- Sponsor's protocol ID
- 06PHR04
- Other IDs
- 2008-A00453-52
- Acronym
- SNA&Sepsis
- Status last verified
- Jul 2010
- First submitted
- 3 Feb 2009
- Last updated
- 19 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Nervous System Alteration Induce by Sepsis:Assessment and Prognosis Impact
- ClinicalTrials.gov ID
- NCT00835913
- Acronym / sponsor ID
- SNA&Sepsis / 06PHR04
- Conditions
- Septic Shock, Severe Sepsis
- Keywords
- Autonomic nervous system, Sepsis shock, severe sepsis, sinusal change, Myocardiac fixing, NTproBNP, Patient in intensive care unit with sepsis shock or severe, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Feb 2009 (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.
Severe sepsis and septic shock are causes of admission in intensive care units.Modification of natriuretic peptid including NT-proBNP and cardiac autonomic nervous system alteration are reported in sepsis shock and severe sepsis and seems to link to patient prognosis admitted to intensive care units.
Detailed description
Our principal aim is to characterize modulation of cardiac sympathic nervous system in sepsis through the study of sinusal change and myocardiac fixing of MIBG.
The second aim is 1)to assess links between alteration of cardiac sympathic nervous system and NT-PRoBNP variations in sepsis and 2)To know prognostic impact in sympathic nervous system compare to NTproBNP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patient transfer in intensive care unit with sepsis chock or severe sepsis define as Bone criteria.
Key inclusion criteria (4 listed)
- Patient over 18 years admitted in intensive care unit and having severe sepsis criteria or septic shock documented or suspected define as Bone Criteria
- hemodynamically stable situation
- sinusal rhythm
- Patient for social security
Key exclusion criteria (9 listed)
- Minors
- Patient under guardianship or trusteeship
- pregnant or lactating women
- diabetic
- cardiomyopathy known and/or treated or detect in admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sinusal variability analysis and myocardic fixation of MIBG performed in 48 hours post admission
Time frame: 48 hours post admission
1 secondary outcome
plasmatic measure of NT-ProBNP and catecholamine at admission, day 2 and last day of hospitalisation
Time frame: 30 days
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 19 Jan 2015.
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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.
SCHWEBEL Carole, PH principal investigator
Unit intensive care
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 Septic Shock and Severe Sepsis, run by University Hospital, Grenoble 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 4 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 19 Jan 2015. 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?
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?
Sinusal variability analysis and myocardic fixation of MIBG performed in 48 hours post admission (time frame: 48 hours post admission). 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 19 Jan 2015.