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Study of Ultrasonographic Cava Femoral Ratio in the Critically Ill Patient With Shock (ECHO-RCF)

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ClinicalTrials.gov Identifier: NCT02891577
Recruitment Status : Unknown
Verified September 2016 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief 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.

Condition or disease Intervention/treatment
Hemodynamic Instability Procedure: Ultrasonography

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Ultrasonographic Cava Femoral Ratio in the Critically Ill Patient With Shock
Study Start Date : March 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock Ultrasound


Intervention Details:
  • Procedure: Ultrasonography
    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.


Primary Outcome Measures :
  1. Ratio of the diameter of the inferior vena cava related to the common femoral vein [ Time Frame: Up to 28 days after ICU admission ]

Biospecimen Retention:   Samples Without DNA
Analysis of plasma creatinine, aspartate aminotransferase, and arterial blood gases.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients receiving catecholamine for shock state at the time of ICU admission.
Criteria

Inclusion Criteria:

  • Adult
  • Need for ICU admission
  • Need for vasopressor (epinephrine or norepinephrine) to obtain a mean arterial pressure at least of 65 mmHg

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891577


Contacts
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Contact: Gaël PITON, MD, PhD 0033381668224 gpiton@chu-besancon.fr

Locations
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France
Centre Hospitalier Universitaire de Besançon Recruiting
Besançon, France, 25030
Contact: Gaël PITON, MD, PhD    0033381668224    gpiton@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Gaël PITON, MD, PhD CHU Besançon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02891577    
Other Study ID Numbers: P/2015/267
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
intra abdominal hypertension
shock
critically ill
Additional relevant MeSH terms:
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Critical Illness
Pathologic Processes
Disease Attributes