Clinical trial NCT01067313: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: 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
Lead sponsor: Fresenius Medical Care France
Sponsor class: INDUSTRY
Collaborators: name: Hospices Civils de Lyon
First posted: 2010-02-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clearance of Urea
timeFrame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
measure: Clearance of creatinine
timeFrame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
measure: Clearance of total protein
timeFrame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
measure: Clearance of albumin
timeFrame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
measure: Clearance of Beta 2-microglobulin
timeFrame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
measure: Free light chains kappa of Immunoglobulins
timeFrame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Secondary outcomes:
measure: Mean arterial pressure
timeFrame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
measure: vasopressor requirement
timeFrame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
measure: PaO2 / FiO2
timeFrame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
measure: Heart rate
timeFrame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
measure: Lactate level
timeFrame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Other outcomes:
Locations:
city: Lyon
country: France
facility: Edouard Herriot Hospital, P Reanimation
Study officials:
affiliation: Hospices Civils de Lyon
name: Bernard Allaouchiche, Professor
role: PRINCIPAL_INVESTIGATOR
References: