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OpenTrials
Completed

NCT Number: NCT03464747

Continuous Central Venous Lactate Monitoring by Intravascular Microdialysis : a Comparison to Sequential Arterial Lactate Measurement During Shock.

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.

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Key information

Conditions

Shock Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. Agreement

    Time frame: Every 4hours for 48hours

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

Secondary outcomes

  1. Interchangeability

    Time frame: Every 4hours for 48hours

    Interchangeability of the variations of the two methods using the trend interchangeability method

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2018
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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