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NCT03700346 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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