Muscle Lactate and Lactate to Pyruvate Ratio Clearance in Septic Shock Patients

Septic Shock Clinical Trial

— ClMLsepsis  

Official title:

Muscle Lactate and Lactate to Pyruvate Ratio Clearance as Useful Biomarkers for the Prediction of Mortality in Septic Shock Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700346
• Other study ID #: MilitaryHospTunis
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2021
• Source: Military Hospital of Tunis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We conducted this study aiming to assess the performance of muscle Lactate and lactate to pyruvate (L/P) ratio clearance in predicting mortality in septic shock patients by using microdialysis.

Description:

Microcirculatory alterations are frequently observed in patients with sepsis. In vivo microdialysis (MD) is a bedside technique that can monitor tissue metabolic changes. We conducted this study aiming to assess the performance of muscle Lactate and lactate to pyruvate (L/P) ratio clearance in predicting mortality in septic shock patients by using microdialysis.

Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline and every 6 hours for 3 days by using muscle microdialysis. Clearances of muscle lactate, and L/P ratio were defined as the percentage change in muscle lactate level or L/P ratio compared to baseline (H0) values. A positive value of clearance means a decrease in the rate of the parameter under study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 31, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients fulfilled the criteria of septic shock

Exclusion Criteria:

• pregnancy, uncontrolled hemorrhage, terminal heart failure, significant valvular heart disease, documented or suspected acute coronary syndrome, and limitations on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve.

• incomplete data

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• microdialysis
Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained by using muscle microdialysis

Locations

Country	Name	City	State
Tunisia	Military Hopital of Tunis	Tunis
Tunisia	Military hospital of tunis	Tunis	Mont Fleury

Sponsors (1)

Lead Sponsor	Collaborator
Military Hospital of Tunis

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearances of muscle lactate, and L/P ratio	Clearances of muscle lactate, and L/P ratio were defined as the percentage change in muscle lactate level or L/P ratio compared to baseline (H0) values.	3 days
Secondary	muscle lactate	Interstitial tissue concentration of lactate	3 days
Secondary	muscle pyruvate	Interstitial tissue concentration of pyruvate	3 days
Secondary	muscle glucose	Interstitial tissue concentration of glucose	3 days
Secondary	muscle glycerol	Interstitial tissue concentration of glycerol	3 days