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

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Device: microdialysis

• Registration Number: NCT03700346
• Lead Sponsor: Military Hospital of Tunis

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-09-30
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-09
• Primary Completion: 2018-10-30
• Study Completion: 2018-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-18
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
survivors	microdialysis	survivor at ICU discharge muscle microdialysis
Non survivors	microdialysis	death before ICU discharge muscle microdialysis

Primary Outcome Measures

Name	Time	Method
Clearances of muscle lactate, and L/P ratio	3 days	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.

Secondary Outcome Measures

Name	Time	Method
muscle glucose	3 days	Interstitial tissue concentration of glucose
muscle lactate	3 days	Interstitial tissue concentration of lactate
muscle pyruvate	3 days	Interstitial tissue concentration of pyruvate
muscle glycerol	3 days	Interstitial tissue concentration of glycerol

Trial Locations

Locations (2)

Military hospital of tunis; 🇹🇳 Tunis, Mont Fleury, Tunisia

Military Hopital of Tunis; 🇹🇳 Tunis, Tunisia