Back to resultsEffects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock
Primary Purpose
Septic Shock
Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
muscle microdialysis
Sponsored by
About this trial
This is an interventional screening trial for Septic Shock focused on measuring continuous haemofiltration, intermittent haemodialysis
Eligibility Criteria
Inclusion Criteria:
- septic shock
Exclusion Criteria:
-
Sites / Locations
- Military Hopital of TunisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CVVHF
IHD for 4 hours
Arm Description
CVVHF for 48 h interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.
Intermittent haemodialysis was carried out during the first 4 h at day 1 and day 2 of the study period. Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.
Outcomes
Primary Outcome Measures
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.
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
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
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
Secondary Outcome Measures
changes in mean arterial blood pressure
changes in heart rate
changes in vasopressor support doses
Full Information
NCT ID
NCT02962700
First Posted
November 4, 2016
Last Updated
November 10, 2016
Sponsor
Military Hospital of Tunis
1. Study Identification
Unique Protocol Identification Number
NCT02962700
Brief Title
Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock
Official Title
Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military Hospital of Tunis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the study was to investigate whether CVVH, in comparison to intermittent haemodialysis (IHD), is able to improve regional perfusion in septic shock patients studied by muscle microdialysis
Detailed Description
A prospective, randomized, clinical study ,including septic shock patients with acute renal failure, aged over 16 years. Patients were randomized to receive either CVVH or IHD for renal replacement therapy. Intermittent haemodialysis was carried out during the first 4 h at day 1 and day 2 of the study period. Systemic haemodynamics and interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
continuous haemofiltration, intermittent haemodialysis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CVVHF
Arm Type
Experimental
Arm Description
CVVHF for 48 h interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.
Arm Title
IHD for 4 hours
Arm Type
Active Comparator
Arm Description
Intermittent haemodialysis was carried out during the first 4 h at day 1 and day 2 of the study period.
Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.
Intervention Type
Device
Intervention Name(s)
muscle microdialysis
Intervention Description
Systemic haemodynamics and interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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
Title
changes in heart rate
Time Frame
at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
Title
changes in vasopressor support doses
Time Frame
at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
septic shock
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zied hajjej
Phone
20358907
Ext
00216
Email
hajjej_zied@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mustapha ferjani
Phone
98329256
Ext
00216
Email
mustapha.ferjani@planet.tn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mustapha ferhjani
Organizational Affiliation
Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia
Official's Role
Study Director
Facility Information:
Facility Name
Military Hopital of Tunis
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mustapha ferjani
Phone
98329256
Email
mustapha.ferjani@planet.tn
First Name & Middle Initial & Last Name & Degree
zied hajjej
Phone
20358907
Email
hajjej_zied@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock
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