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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 21 November 2016
Main ID:  NCT02962700
Date of registration: 04/11/2016
Prospective Registration: No
Primary sponsor: Military Hospital of Tunis
Public title: Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock
Scientific title: Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock
Date of first enrolment: January 2016
Target sample size: 100
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02962700
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening  
Phase:  N/A
Countries of recruitment
Tunisia
Contacts
Name:     zied hajjej
Address: 
Telephone: 20358907
Email: hajjej_zied@hotmail.com
Affiliation: 
Name:     mustapha ferjani
Address: 
Telephone: 98329256
Email: mustapha.ferjani@planet.tn
Affiliation: 
Name:     mustapha ferhjani
Address: 
Telephone:
Email:
Affiliation:  Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia
Key inclusion & exclusion criteria

Inclusion Criteria:

- septic shock

Exclusion Criteria:



Age minimum: 16 Years
Age maximum: 90 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Septic Shock
Intervention(s)
Device: muscle microdialysis
Primary Outcome(s)
changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle [Time Frame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement]
changes in the concentration of glucose (mmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle. [Time Frame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement]
changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle [Time Frame: at baseline, 6, 12,18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement]
changes in the concentration of lactate (mmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle [Time Frame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement]
Secondary Outcome(s)
changes in mean arterial blood pressure [Time Frame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement]
changes in heart rate [Time Frame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement]
changes in vasopressor support doses [Time Frame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement]
Secondary ID(s)
CVVHFmicro
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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