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| Name | Class |
|---|---|
| Hospices Civils de Lyon | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dialyzer Ultraflux EMiC2 | Experimental | Dialyzer Ultraflux EMiC2 used in Continuous Hemodialysis |
|
| Dialyzer Ultraflux AV1000S | Active Comparator | Dialyzer Ultraflux AV1000S used in continuous Hemofiltration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialyzer Ultraflux EMiC2 | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Allaouchiche, Professor | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edouard Herriot Hospital, P Reanimation | Lyon | 69003 | France |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| Dialyzer Ultraflux AV1000S | Device | 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. |
|
| 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 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |