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

November 10, 2016 updated by: Hajjej Zied, Military Hospital of Tunis
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia, 1008
        • Recruiting
        • Military Hopital of Tunis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • septic shock

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CVVHF
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
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.
Active Comparator: IHD for 4 hours

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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
changes in heart rate
Time Frame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
changes in vasopressor support doses
Time Frame: at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement
at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Military Hospital of Tunis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 4, 2016

First Submitted That Met QC Criteria

November 10, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

November 10, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVVHFmicro

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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