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Completed

NCT Number: NCT01067313

Continuous Hemodialysis With an Enhanced Middle Molecule Clearance Membrane

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Clearance of Urea

    Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  2. Clearance of creatinine

    Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  3. Clearance of total protein

    Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  4. Clearance of albumin

    Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  5. Clearance of Beta 2-microglobulin

    Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  6. Free light chains kappa of Immunoglobulins

    Time frame: At 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

Secondary outcomes

  1. Mean arterial pressure

    Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  2. vasopressor requirement

    Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  3. PaO2 / FiO2

    Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  4. Heart rate

    Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

  5. Lactate level

    Time frame: Before connecting Patient and at 15 minutes, 60 minutes, 4 hours, 12 hours, 24 hours and 48 hours

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care France

Industry

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Feb 11, 2010
Registry last updated
Mar 29, 2011

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.

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