Continuous Central Venous Lactate Monitoring by Intravasc... | NCT03464747

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2017Actual

Primary Completion Date

Jun 15, 2018Actual

Completion Date

Jun 15, 2018Actual

First Submitted Date

Mar 8, 2018

First Submission Date that Met QC Criteria

Mar 8, 2018

First Posted Date

Mar 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2020

Last Update Posted Date

Aug 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden)	Device	continuous measurement of venous lactate through a central venous catheter by microdialysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Agreement	Agreement between sequential arterial blood lactate measurement and continuous venous lactate obtained by microdialysis	Every 4hours for 48hours

Secondary Outcomes

Measure	Description	Time Frame
Interchangeability	Interchangeability of the variations of the two methods using the trend interchangeability method	Every 4hours for 48hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria: Pregnant women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

ICU patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nîmes - Hôpital Universitaire Carémeau		Nîmes		30029	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms