Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Continuous Haemofiltration vs Intermittent Haemodialysis on Microcirculatory Parameters in Septic Shock

Conditions
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Septic Shock

Intervention / Treatment
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* Device: muscle microdialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: septic shock Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CVVHF<br>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. | Device: muscle microdialysis<br>* 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.<br>|
| Active Comparator: IHD for 4 hours<br>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. | Device: muscle microdialysis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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 |  | at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement | 
| 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 |  | 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 |  | at baseline, 6, 12,18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in mean arterial blood pressure |  | at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement | 
| changes in heart rate |  | at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement | 
| changes in vasopressor support doses |  | at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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continuous haemofiltration, intermittent haemodialysis