Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane

Evaluation of Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane in Intensive Care

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Device: Dialyzer Ultraflux EMiC2; Device: Dialyzer Ultraflux AV1000S

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Edouard Herriot Hospital, P Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dialyzer Ultraflux EMiC2; Dialyzer Ultraflux EMiC2 used in Continuous Hemodialysis	Device: Dialyzer Ultraflux EMiC2; 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.
Active Comparator: Dialyzer Ultraflux AV1000S; Dialyzer Ultraflux AV1000S used in continuous Hemofiltration	Device: Dialyzer Ultraflux AV1000S; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clearance of Urea	At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Clearance of creatinine	At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Clearance of total protein	At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Clearance of albumin	At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Clearance of Beta 2-microglobulin	At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Free light chains kappa of Immunoglobulins	At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean arterial pressure	Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
vasopressor requirement	Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
PaO2 / FiO2	Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Heart rate	Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Lactate level	Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

Collaborators and Investigators

• Sponsor: Fresenius Medical Care France
• Collaborators: Hospices Civils de Lyon
• Investigators: Principal Investigator: Bernard Allaouchiche, Professor, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: February 10, 2010
• First Submitted That Met QC Criteria: February 10, 2010
• First Posted (Estimate): February 11, 2010

Study Record Updates

• Last Update Posted (Estimate): March 29, 2011
• Last Update Submitted That Met QC Criteria: March 28, 2011
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Septic shock; Renal replacement therapy; Acute kidney injury; Blood purification; continuous hemodialysis; continuous hemofiltration; High Cut-off membrane; "Enhanced middle molecule clearance" membrane
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: HD-RE-01-F