Back to resultsMuscle Lactate and Lactate to Pyruvate Ratio Clearance in Septic Shock Patients (ClMLsepsis)
Primary Purpose
Septic Shock
Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
microdialysis
Sponsored by
About this trial
This is an interventional other trial for Septic Shock
Eligibility Criteria
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
Sites / Locations
- Military hospital of tunis
- Military Hopital of Tunis
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
survivors
Non survivors
Arm Description
survivor at ICU discharge muscle microdialysis
death before ICU discharge muscle microdialysis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
muscle lactate
Interstitial tissue concentration of lactate
muscle pyruvate
Interstitial tissue concentration of pyruvate
muscle glucose
Interstitial tissue concentration of glucose
muscle glycerol
Interstitial tissue concentration of glycerol
Full Information
NCT ID
NCT03700346
First Posted
September 30, 2018
Last Updated
April 18, 2021
Sponsor
Military Hospital of Tunis
1. Study Identification
Unique Protocol Identification Number
NCT03700346
Brief Title
Muscle Lactate and Lactate to Pyruvate Ratio Clearance in Septic Shock Patients
Acronym
ClMLsepsis
Official Title
Muscle Lactate and Lactate to Pyruvate Ratio Clearance as Useful Biomarkers for the Prediction of Mortality in Septic Shock Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Military Hospital of Tunis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
survivors
Arm Type
Other
Arm Description
survivor at ICU discharge muscle microdialysis
Arm Title
Non survivors
Arm Type
Other
Arm Description
death before ICU discharge muscle microdialysis
Intervention Type
Device
Intervention Name(s)
microdialysis
Intervention Description
Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained by using muscle microdialysis
Primary Outcome Measure Information:
Title
Clearances of muscle lactate, and L/P ratio
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
muscle lactate
Description
Interstitial tissue concentration of lactate
Time Frame
3 days
Title
muscle pyruvate
Description
Interstitial tissue concentration of pyruvate
Time Frame
3 days
Title
muscle glucose
Description
Interstitial tissue concentration of glucose
Time Frame
3 days
Title
muscle glycerol
Description
Interstitial tissue concentration of glycerol
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zied Hajjej, dr
Organizational Affiliation
Military hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Military hospital of tunis
City
Tunis
State/Province
Mont Fleury
ZIP/Postal Code
1008
Country
Tunisia
Facility Name
Military Hopital of Tunis
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Muscle Lactate and Lactate to Pyruvate Ratio Clearance in Septic Shock Patients
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