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

Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464747
• Other study ID #: IRB : 16.09.02
• Status: Completed
• Start date: February 17, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Shock

Intervention

Device:
• EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden)
continuous measurement of venous lactate through a central venous catheter by microdialysis

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement	Agreement between sequential arterial blood lactate measurement and continuous venous lactate obtained by microdialysis	Every 4hours for 48hours
Secondary	Interchangeability	Interchangeability of the variations of the two methods using the trend interchangeability method	Every 4hours for 48hours