- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03700346
Muscle Lactate and Lactate to Pyruvate Ratio Clearance in Septic Shock Patients (ClMLsepsis)
Muscle Lactate and Lactate to Pyruvate Ratio Clearance as Useful Biomarkers for the Prediction of Mortality in Septic Shock Patients
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Tunis, Tunisia, 1008
- Military Hopital of Tunis
-
-
Mont Fleury
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Tunis, Mont Fleury, Tunisia, 1008
- Military Hospital of Tunis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: survivors
survivor at ICU discharge muscle microdialysis
|
Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained by using muscle microdialysis
|
Other: Non survivors
death before ICU discharge muscle microdialysis
|
Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained by using muscle microdialysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clearances of muscle lactate, and L/P ratio
Time Frame: 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.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
muscle lactate
Time Frame: 3 days
|
Interstitial tissue concentration of lactate
|
3 days
|
muscle pyruvate
Time Frame: 3 days
|
Interstitial tissue concentration of pyruvate
|
3 days
|
muscle glucose
Time Frame: 3 days
|
Interstitial tissue concentration of glucose
|
3 days
|
muscle glycerol
Time Frame: 3 days
|
Interstitial tissue concentration of glycerol
|
3 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: zied Hajjej, dr, Military Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MilitaryHospTunis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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