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

Not Applicable

• Conditions: Septic Shock

• Registration Number: NCT02962700
• Lead Sponsor: Military Hospital of Tunis

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.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-11
• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-11-10
• Last Update Submitted: 2016-11-10
• Study First Posted: 2016-11-11
• Last Update Posted: 2016-11-11
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• septic shock

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Military Hopital of Tunis; 🇹🇳 Tunis, Tunisia