Continuous MONItoring of Blood LActate and Glucose Levels Using a New Central Veinous Microdialysis Catheter Device

Other Functional Disturbances Following Cardiac Surgery Clinical Trial

— MONILAG  

Official title:

Monitorage Continu du Lactate et de la glycémie Par Microdialyse : Une étude de Validation en Chirurgie Cardiaque.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296593
• Other study ID #: A14-D36-VOL.22
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: March 6, 2017
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: March 2017
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Continuous lactate and glucose blood levels

Description:

MAQUET Group offers a new device that gives real time blood lactate and glucose levels. It is a new central veinous catheter with a microdialysis system. It is planted in the superior vena cava. It has not yet been used and validated with a clinical purpose, and particularly in cardiac surgery.

For now, reference method for determining blood lactate and glucose levels is co oxymetry.

This new simple device could provide great fluency for determining blood lactate and glucose levels. It could allow medical teams gain time for diagnosis and treatment of both hyperlactatemia and hyperglycemia.

The primary outcome of this study was to compare blood lactate and glucose absolute measures provided with the MAQUET new device (Maquet Critical Care AB, Solna, Sweden) and with co oxymetry.

The secondary outcome of this study was to compare variations of these absolutes measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women more than 18 years old.

• Cardiac surgery.

• Central veinous catheter in superior vena cava.

Exclusion Criteria:

• Men or women less than 18 years old.

• Pregnant women.

• Central veinous catheter not in superior vena cava.

Related Conditions & MeSH terms

• Other Functional Disturbances Following Cardiac Surgery
• Pathologic Processes

Intervention

Device:
• comparison of blood lactate and glucose levels
comparison of blood lactate and glucose levels with the reference method (co oxymetry) and a new central veinous catheter microdialysis system provided by MAQUET. (Critical Care AB, Solna, Sweden.)

Locations

Country	Name	City	State
France	CHU de Caen	Caen	Basse Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of absolute blood lactate and glucose levels with the reference method (co oxymetry) and a new method using a device providing real time measures of lactate and glycemia with a central veinous catheter microdialysis system.	Central veinous catheter, EIRUS (Maquet Critical Care AB, Solna, Sweden)	1 day
Secondary	comparison of variations of blood lactate and glycemia levels with the reference method (co oxymetry) and a new method using a device providing real time measures of lactate and glycemia. (EIRUS) with a central veinous catheter microdialysis system.	Central veinous catheter, EIRUS (Maquet Critical Care AB, Solna, Sweden)	1 day