NCT02296593

Brief Summary

Continuous lactate and glucose blood levels

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

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

November 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

November 18, 2014

Last Update Submit

March 6, 2017

Conditions

Keywords

lactatecontinuous lactate monitoringcontinuous blood glucose monitoringEIRUSblood glucosecardiac surgerycentral veinous cathetermicrodialysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

    1 day

Interventions

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.)

Also known as: EIRUS, continuous lactate monitoring, continuous glycemia monitoring, central veinous catheter, microdialysis system, MAQUET

Eligibility Criteria

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

Consecutive patients of cardiac surgery. (planned or for emergencies)

You may qualify if:

  • Men or women more than 18 years old.
  • Cardiac surgery.
  • Central veinous catheter in superior vena cava.

You may not qualify if:

  • Men or women less than 18 years old.
  • Pregnant women.
  • Central veinous catheter not in superior vena cava.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Caen

Caen, Basse Normandie, 14000, France

Location

Related Publications (1)

  • Gouezel C, Lorne E, Bonnet V, Fradin S, Saplacan V, Gerard JL, Hanouz JL, Fellahi JL, Fischer MO; FHT (French Hemodynamic Team). Assessment of changes in lactate concentration with intravascular microdialysis during high-risk cardiac surgery using the trend interchangeability method. Br J Anaesth. 2017 Dec 1;119(6):1110-1117. doi: 10.1093/bja/aex338.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples for determination of lactate and glucose blood levels

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

November 1, 2014

Primary Completion

May 1, 2016

Study Completion

November 1, 2016

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations