Hemodynamic InstabilityECHO-RCFNCT02891577
Study of Ultrasonographic Cava Femoral Ratio in the Critically Ill Patient With Shock
An observational study of Hemodynamic Instability, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study aims to describe the ratio of the diameter of inferior vena cava to the common femoral vein measured by ultrasonography in critically ill patients with shock, and to evaluate the potential link between this ratio and the existence of intra-abdominal disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Ultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Sep 2017
- 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: Critically ill patients receiving catecholamine for shock state at the time of ICU admission.
Who may be able to join
- Adult
- Need for ICU admission
- Need for vasopressor (epinephrine or norepinephrine) to obtain a mean arterial pressure at least of 65 mmHg
Who cannot join
- Deep venous thrombosis related to inferior vena cava or common femoral veins
- Inability to measure inferior vena cava and common femoral vein diameters using ultrasonography
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Besançon
Besançon, 25030
Gaël PITON, MD, PhD, 0033381668224, gpiton@chu-besancon.fr
About this study
This study aims to describe the ratio of the diameter of inferior vena cava to the common femoral vein measured by ultrasonography in critically ill patients with shock, and to evaluate the potential link between this ratio and the existence of intra-abdominal disease.
Read the detailed description
Among patients presenting with severe abdominal disease and shock, observations shown that the diameter of the common femoral vein was larger than the inferior vena cava. The hypothesis is that this observation could be secondary to a compression of the inferior vena cava related to an increased intra abdominal pressure.
- Conditions
- Hemodynamic Instability
- Being tested
- Ultrasonography
- Keywords
- intra abdominal hypertension, shock, critically ill
- Medical subject headings
- Intra-Abdominal Hypertension, Shock, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyProcedure or surgery
At the time of ICU admission, among critically ill patients with shock, the investigators will measure the diameter of the common femoral vein and that of the inferior vena cava by ultrasonography.
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of the diameter of the inferior vena cava related to the common femoral vein
Measured: Up to 28 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaël PITON, MD, PhD, Principal investigator, CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891577
- Sponsor's protocol ID
- P/2015/267
- Acronym
- ECHO-RCF
- Status last verified
- Sep 2016
- First submitted
- 11 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Ultrasonographic Cava Femoral Ratio in the Critically Ill Patient With Shock
- ClinicalTrials.gov ID
- NCT02891577
- Acronym / sponsor ID
- ECHO-RCF / P/2015/267
- Conditions
- Hemodynamic Instability
- Keywords
- intra abdominal hypertension, shock, critically ill
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 7 Sep 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.
This study aims to describe the ratio of the diameter of inferior vena cava to the common femoral vein measured by ultrasonography in critically ill patients with shock, and to evaluate the potential link between this ratio and the existence of intra-abdominal disease.
Detailed description
Among patients presenting with severe abdominal disease and shock, observations shown that the diameter of the common femoral vein was larger than the inferior vena cava. The hypothesis is that this observation could be secondary to a compression of the inferior vena cava related to an increased intra abdominal pressure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients receiving catecholamine for shock state at the time of ICU admission.
Key inclusion criteria (3 listed)
- Adult
- Need for ICU admission
- Need for vasopressor (epinephrine or norepinephrine) to obtain a mean arterial pressure at least of 65 mmHg
Key exclusion criteria (2 listed)
- Deep venous thrombosis related to inferior vena cava or common femoral veins
- Inability to measure inferior vena cava and common femoral vein diameters using ultrasonography
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 |
|---|---|---|
| UltrasonographyAt the time of ICU admission, among critically ill patients with shock, the investigators will measure the diameter of the common femoral vein and that of the inferior vena cava by ultrasonography. | Procedure or surgery | – |
Primary outcome
Ratio of the diameter of the inferior vena cava related to the common femoral vein
Time frame: Up to 28 days after ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- 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.
Gaël PITON, MD, PhD principal investigator
CHU Besançon
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 Hemodynamic Instability, run by Centre Hospitalier Universitaire de Besancon 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 2 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 7 Sep 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaël PITON, MD, PhD (0033381668224, gpiton@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of the diameter of the inferior vena cava related to the common femoral vein (time frame: Up to 28 days after ICU 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 7 Sep 2016.