NCT04028102

Brief Summary

Initial sepsis treatment requires fluid challenge. While the Surviving Sepsis Campaign indicates a 30 ml/kg volume, there is concerns on the efficacy and safety of this fixed volume. The aim of this study is to assess the difference between fluid volume determined par cardiac and lung Ultrasound versus the fixed 30 ml/kg.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 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

Study Start

First participant enrolled

October 1, 2016

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

3.4 years

First QC Date

July 17, 2019

Last Update Submit

July 19, 2019

Conditions

Sepsis

Keywords

sepsistreatmentfluid challenge

Outcome Measures

Primary Outcomes (1)

  • concordance of fluid volume

    number of patients with delta FC volume \> 20% between US technique and the theoretical 30 ml/kg

    3 hours after FC initiation

Eligibility Criteria

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

patients with sepsis and hypotension in the Emergency Department

You may qualify if:

  • patients \>18 years old with sepsis as defined by SEPSIS-3 and with hypotension (MAP \< 65 mm Hg or lactate \> 2 mmol/l)

You may not qualify if:

  • documented end-of-life
  • pregnancy
  • B/B initial profile to the first Lung US

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 22, 2019

Study Start

October 1, 2016

Primary Completion

March 1, 2020

Study Completion

September 1, 2020

Last Updated

July 22, 2019

Record last verified: 2019-07

Locations

FR(1)