NCT03464747

Brief Summary

During shock, arterial hypotension, inadequate cardiac output and microcirculatory alterations lead to tissue hypoxia, multiple organ failure and death. Arterial lactate is considered as the best marker of tissue hypoxia. A lactate decrease during the first 6 hour is strongly associated with better outcome and may be used as a target for assessing the efficiency of shock resuscitation. The EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden) is a new device allowing the continuous measurement of venous lactate through a central venous catheter. However, before being used extensively, such device needs to be evaluated concerning its accuracy. The aim of the present study is to assess the reliability of this device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

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

February 17, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 14, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

March 8, 2018

Last Update Submit

August 11, 2020

Conditions

Shock

Keywords

Lactic Acid

Outcome Measures

Primary Outcomes (1)

  • Agreement

    Agreement between sequential arterial blood lactate measurement and continuous venous lactate obtained by microdialysis

    Every 4hours for 48hours

Secondary Outcomes (1)

  • Interchangeability

    Every 4hours for 48hours

Interventions

EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden)DEVICE

continuous measurement of venous lactate through a central venous catheter by microdialysis

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients

You may qualify if:

  • Acute circulatory failure defined as : systolic blood pressure\<90mmHg or mean arterial pressure \<65mmHg and blood lactate \> 2mmol/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic 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

March 8, 2018

First Posted

March 14, 2018

Study Start

February 17, 2017

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations

FR(1)