Clinical trial NCT02962700: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Keywords: continuous haemofiltration
intermittent haemodialysis
Lead sponsor: Military Hospital of Tunis
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion Criteria:

* septic shock

Exclusion Criteria:

-

Primary outcomes:
measure: 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.
timeFrame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
measure: 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
timeFrame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
measure: 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
timeFrame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
measure: 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
timeFrame: at baseline, 6, 12,18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
Secondary outcomes:
measure: changes in mean arterial blood pressure
timeFrame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
measure: changes in heart rate
timeFrame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
measure: changes in vasopressor support doses
timeFrame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military Hopital of Tunis
Study officials:
affiliation: Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia
name: mustapha ferhjani
role: STUDY_DIRECTOR
References: