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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02962700
• Other study ID #: CVVHFmicro
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2016
• Last updated: November 10, 2016
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: November 2016
• Source: Military Hospital of Tunis
• Contact: zied hajjej
• Phone: 20358907
• Email: hajjej_zied[@]hotmail.com
• Is FDA regulated: No
• Health authority: Tunisia: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 90 Years

Eligibility

Inclusion Criteria:

• septic shock

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Device:
• muscle microdialysis
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.

Locations

Country	Name	City	State
Tunisia	Military Hopital of Tunis	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Military Hospital of Tunis

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	changes in mean arterial blood pressure		at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement	Yes
Secondary	changes in heart rate		at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement	Yes
Secondary	changes in vasopressor support doses		at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement	Yes