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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
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.
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.
Edouard Herriot Hospital, P Reanimation
Lyon, France
Clearance of Urea
Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Clearance of creatinine
Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Clearance of total protein
Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Clearance of albumin
Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Clearance of Beta 2-microglobulin
Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Free light chains kappa of Immunoglobulins
Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Mean arterial pressure
Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
vasopressor requirement
Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
PaO2 / FiO2
Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Heart rate
Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
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Lactate level
Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours