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Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Dialyzer Ultraflux EMiC2
Dialyzer Ultraflux AV1000S
Sponsored by
Fresenius Medical Care France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Intensive Care Unit, continuous hemodialysis, continuous hemofiltration, High Cut-off membrane, "Enhanced middle molecule clearance" membrane, Septic shock, Acute kidney injury, Blood purification, Renal replacement therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged over 18 years.
  • ICU patients with septic shock and AKI requiring continuous renal replacement.
  • Patient able to agree to be enrolled in the study with informed consent. If the patient can not provide consent, only the consent of family members will be sought if they are present and, to default, the opinion of trustworthy person under article L.1111-6 of the French Health Code. If there is no family present, or trustworthy person designated, the subject will not be included in the study.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Participation in another research protocol.
  • People particularly vulnerable as defined in Articles L.1121-5, L.1121-6, L.1121-7, L.1121-8 et L.1122-1-2 of the French Health Code.

Sites / Locations

  • Edouard Herriot Hospital, P Reanimation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dialyzer Ultraflux EMiC2

Dialyzer Ultraflux AV1000S

Arm Description

Dialyzer Ultraflux EMiC2 used in Continuous Hemodialysis

Dialyzer Ultraflux AV1000S used in continuous Hemofiltration

Outcomes

Primary Outcome Measures

Clearance of Urea
Clearance of creatinine
Clearance of total protein
Clearance of albumin
Clearance of Beta 2-microglobulin
Free light chains kappa of Immunoglobulins

Secondary Outcome Measures

Mean arterial pressure
vasopressor requirement
PaO2 / FiO2
Heart rate
Lactate level

Full Information

First Posted
February 10, 2010
Last Updated
March 28, 2011
Sponsor
Fresenius Medical Care France
Collaborators
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01067313
Brief Title
Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane
Official Title
Evaluation of Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane in Intensive Care
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fresenius Medical Care France
Collaborators
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to demonstrate equivalence in terms of molecule removal between continuous hemodialysis using an "enhanced middle molecule clearance" membrane(Ultraflux EMiC2) and continuous hemofiltration using a standard membrane (Ultraflux AV1000S) in ICU patients requiring continuous renal replacement therapy.
Detailed Description
In sepsis, the removal of middle molecular weight molecules such as cytokines (also called blood purification), has shown a great interest in intensive care during the last decades. Indeed, these cytokines are involved in the development of the multi-organ failure syndrome when patients are in septic shock. There is some evidence to suggest that extracorporeal therapies (hemofiltration-hemodialysis)are interesting tools to modulate the inflammatory response and to restore the immune homeostasis. However, hemodialysis using "conventional" membranes does not allow the removal of middle molecules. Conversely, high-volume hemofiltration is an appropriate therapy but it has a lot of drawbacks due to the high ultrafiltration rates (removal of beneficial small molecules, technical and economical issues due to the use of large amounts of fluid replacement). Finally, high cut-off hemofiltration has been reported to be associated with significant albumin loss. Therefore, continuous "enhanced middle molecule clearance" hemodialysis could be an interesting alternative, making possible the removal of these middle molecules without significant albumin loss and with some theoretical advantages (reduced cost due to the possibility to produce the dialysate from a water circuit, decreased nursing workload). The aim of this study is to assess the clearances of different kind of molecules (small, middle and large) when continuous enhanced middle molecule clearance hemodialysis is applied to septic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Intensive Care Unit, continuous hemodialysis, continuous hemofiltration, High Cut-off membrane, "Enhanced middle molecule clearance" membrane, Septic shock, Acute kidney injury, Blood purification, Renal replacement therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialyzer Ultraflux EMiC2
Arm Type
Experimental
Arm Description
Dialyzer Ultraflux EMiC2 used in Continuous Hemodialysis
Arm Title
Dialyzer Ultraflux AV1000S
Arm Type
Active Comparator
Arm Description
Dialyzer Ultraflux AV1000S used in continuous Hemofiltration
Intervention Type
Device
Intervention Name(s)
Dialyzer Ultraflux EMiC2
Intervention Description
Dialysate flow rate = 40 ml/kg/h The treatment duration may be variable depending on modifications in patient health status, but will not exceed 3 sessions of 48 hours each.
Intervention Type
Device
Intervention Name(s)
Dialyzer Ultraflux AV1000S
Intervention Description
Ultrafiltration flow rate = 40 ml/kg/h The blood flow rate will be adjusted to obtain a filtration fraction of 20%. Reinjection = 100% postdilution. The treatment duration may be variable depending on modifications in patient health status, but will not exceed 3 sessions of 48 hours each.
Primary Outcome Measure Information:
Title
Clearance of Urea
Time Frame
At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Title
Clearance of creatinine
Time Frame
At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Title
Clearance of total protein
Time Frame
At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Title
Clearance of albumin
Time Frame
At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Title
Clearance of Beta 2-microglobulin
Time Frame
At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Title
Free light chains kappa of Immunoglobulins
Time Frame
At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Secondary Outcome Measure Information:
Title
Mean arterial pressure
Time Frame
Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Title
vasopressor requirement
Time Frame
Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Title
PaO2 / FiO2
Time Frame
Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Title
Heart rate
Time Frame
Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Title
Lactate level
Time Frame
Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged over 18 years. ICU patients with septic shock and AKI requiring continuous renal replacement. Patient able to agree to be enrolled in the study with informed consent. If the patient can not provide consent, only the consent of family members will be sought if they are present and, to default, the opinion of trustworthy person under article L.1111-6 of the French Health Code. If there is no family present, or trustworthy person designated, the subject will not be included in the study. Exclusion Criteria: Pregnancy or lactation. Participation in another research protocol. People particularly vulnerable as defined in Articles L.1121-5, L.1121-6, L.1121-7, L.1121-8 et L.1122-1-2 of the French Health Code.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Allaouchiche, Professor
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edouard Herriot Hospital, P Reanimation
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

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Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane

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