NCT02728791

Brief Summary

Correlation study between the data provided by two measurement systems, trans- pulmonary thermodilution and ClearSight © (non invasive), to determine the interest in routine use (cardiac output, cardiac index, stroke volume and blood pressure).

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 10, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

2.6 years

First QC Date

March 25, 2016

Last Update Submit

January 23, 2018

Conditions

ShockCardiac Output, Low

Outcome Measures

Primary Outcomes (1)

  • Comparison of values and changes in cardiac index between the two devices

    2 days

Secondary Outcomes (3)

  • Comparison of values and variations in mean arterial pressure between the two devices

    2 days

  • Comparison of values and variations in mean cardiac output between the two devices

    2 days

  • Comparison of values and variations in mean stroke volume variation between the two devices

    2 days

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults patients hospitalized in ICU with hemodynamic failure requiring vasoactive drugs

You may qualify if:

  • age\>18
  • hospitalized in surgical ICU, with hemodynamic instability or vaso-active drugs
  • No opposition formulated

You may not qualify if:

  • Impossibility of establishment of one of the cardiac output measurement devices
  • Pregnant woman
  • Refuse to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU BREST, Hôpital de la Cavale Blanche

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

ShockCardiac Output, Low

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesSigns and Symptoms

Study Officials

  • Olivier O HUET

    CHRU de Brest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Ferréol JF OILLEAU

CONTACT

0298347961jean-ferreol.oilleau@chu-brest.fr

olivier O HUET

CONTACT

0298347288olivier.huet@chu-brest.fr

Study Design

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

Study Record Dates

First Submitted

March 25, 2016

First Posted

April 5, 2016

Study Start

May 10, 2016

Primary Completion

December 10, 2018

Study Completion

December 10, 2018

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations

FR(1)