Edouard Herriot Hospital, P Reanimation
Lyon, 69003, France
NCT Number: NCT01067313
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Lyon, 69003, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours
Fresenius Medical Care France
Industry
Evaluation of Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane in Intensive Care
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03472079
Acute Kidney Injury, Female Urogenital Diseases
Amiens, France
View Trial DetailsNCT05900284
Acute Kidney Injury, Female Urogenital Diseases
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT07569406
Acute Kidney Injury, Female Urogenital Diseases
Pamplona, Navarre, Spain
View Trial DetailsNCT04316884
Acute Kidney Injury, Acute Respiratory Distress Syndrome
Uppsala, Uppsala County, Sweden
View Trial Details