NCT02891577

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

1.4 years

First QC Date

August 11, 2016

Last Update Submit

September 6, 2016

Conditions

Keywords

intra abdominal hypertensionshockcritically ill

Outcome Measures

Primary Outcomes (1)

  • Ratio of the diameter of the inferior vena cava related to the common femoral vein

    Up to 28 days after ICU admission

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Critically ill patients receiving catecholamine for shock state at the time of ICU admission.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25030, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Analysis of plasma creatinine, aspartate aminotransferase, and arterial blood gases.

MeSH Terms

Conditions

Intra-Abdominal HypertensionShockCritical Illness

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Gaël PITON, MD, PhD

    CHU Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaël PITON, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

September 7, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

September 7, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations