Severe SepsisNCT00398736
A Non-invasive Approach to the Assessment of Volume Status in Mechanically Ventilated Septic Patients.
An observational study of Severe Sepsis and Septic Shock, run by Charite University, Berlin, Germany.
Trial summary
To evaluate the use of sonographic inferior caval vein assessment in mechanically ventilated septic patients. Volume assessment in mechanically ventilated patients with inflammation is of major importance to guide fluid therapy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Severe Sepsis, Septic Shock
- What is being tested?
- sonographic measurement of inferior caval vein diameter
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Critically ill patients with sepsis
Who may be able to join
- age 18-90
- presence of severe sepsis and septic shock
- invasive hemodynamic monitoring using the picco system
Who cannot join
None listed.
About this study
To evaluate the use of sonographic inferior caval vein assessment in mechanically ventilated septic patients.
Volume assessment in mechanically ventilated patients with inflammation is of major importance to guide fluid therapy. The researchers investigated whether measurement of caval vein diameter correlates with invasively assessed volume-based hemodynamic parameters.
- Conditions
- Severe Sepsis, Septic Shock
- Being tested
- sonographic measurement of inferior caval vein diameter
- Keywords
- Presence of severe sepsis and septic shock, mechanical ventilation
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonographic measurement of inferior caval vein diameterProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Case only
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Joerg C Dr. Schefold, MD, Principal investigator, Charite University Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398736
- Sponsor's protocol ID
- Caval vein sonography
- Status last verified
- Jul 2009
- First submitted
- 13 Nov 2006
- Last updated
- 15 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-invasive Approach to the Assessment of Volume Status in Mechanically Ventilated Septic Patients.
- ClinicalTrials.gov ID
- NCT00398736
- Acronym / sponsor ID
- Caval vein sonography
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- Presence of severe sepsis and septic shock, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- First posted
- 14 Nov 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.
To evaluate the use of sonographic inferior caval vein assessment in mechanically ventilated septic patients.
Volume assessment in mechanically ventilated patients with inflammation is of major importance to guide fluid therapy. The researchers investigated whether measurement of caval vein diameter correlates with invasively assessed volume-based hemodynamic parameters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients with sepsis
Key inclusion criteria (3 listed)
- age 18-90
- presence of severe sepsis and septic shock
- invasive hemodynamic monitoring using the picco system
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| sonographic measurement of inferior caval vein diameter | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 15 Jul 2009.
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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.
Joerg C Dr. Schefold, MD principal investigator
Charite University Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Septic Shock, run by Charite University, Berlin, Germany.
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 0 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 15 Jul 2009. 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?
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.
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 15 Jul 2009.