Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067313
• Other study ID #: HD-RE-01-F
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 10, 2010
• Last updated: March 28, 2011
• Start date: July 2008
• Est. completion date: January 2011

Study information

• Verified date: February 2010
• Source: Fresenius Medical Care France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Edouard Herriot Hospital, P Reanimation	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Medical Care France	Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clearance of Urea		At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours	No
Primary	Clearance of creatinine		At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours	No
Primary	Clearance of total protein		At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours	No
Primary	Clearance of albumin		At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours	No
Primary	Clearance of Beta 2-microglobulin		At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours	No
Primary	Free light chains kappa of Immunoglobulins		At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours	No
Secondary	Mean arterial pressure		Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours	No
Secondary	vasopressor requirement		Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours	No
Secondary	PaO2 / FiO2		Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours	No
Secondary	Heart rate		Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours	No
Secondary	Lactate level		Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours	No