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Stability of Middle Molecule Clearance (EMIC2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01308073
First Posted: March 3, 2011
Last Update Posted: December 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fresenius Medical Care Deutschland GmbH
Information provided by (Responsible Party):
Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
  Purpose
The investigators aim to show, whether all middle molecules are included in the clearance and whether this clearance is stable until 72 hours.

Condition Intervention
Continuous Hemodialysis Device: Hemodialysis with EMIC 2 filters

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-time Stability of Middle Molecule Clearance During CI-Ca CVVHD

Resource links provided by NLM:


Further study details as provided by Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Clearance of Urea [ Time Frame: up to 72 h ]
  • Clearance of Cystatin C [ Time Frame: up to 72 h ]
  • Clearance of creatinine [ Time Frame: up to 72 h ]
  • Clearance of Beta2-Microglobulin [ Time Frame: up to 72 h ]
  • Clearance of Osteocalcin [ Time Frame: up to 72 h ]
  • Free light chains kappa of Immunoglobulins [ Time Frame: up to 72 h ]
  • Clearance of albumin [ Time Frame: up to 72 h ]

Secondary Outcome Measures:
  • Mean arterial pressure [ Time Frame: up to 72 h ]
  • Vasopressor requirement [ Time Frame: up to 72 h ]
  • Heart rate [ Time Frame: up to 72 h ]

Enrollment: 15
Study Start Date: March 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
EMIC 2 dialysis
Patients on ICU requiring dialysis for acute renal insufficiency
Device: Hemodialysis with EMIC 2 filters
Patients with indication for routine continuous hemodialysis due to acute renal insufficiency

Detailed Description:
A better middle molecule clearance has been shown until 24 hours of duration. The investigators will extend our observations until 72 hours.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of surgical intensive care unit
Criteria

Inclusion Criteria:

  • informed consent
  • age>18 years
  • acute renal insufficiency with indication for continuous hemodialysis, according to RILFE classification F: serum creatinine increase > 3-fold or serum creatinine > 4mg/dl with acute increase of >0,5mg/dl Urine Output <0,3mg/kg/h for 24 h or anuria for 12 h
  • body weight:60-80kg
  • anticoagulation with citrate possible and indicated
  • Dose for hemodialysis of 2l/h

Exclusion Criteria:

  • participation in another clinical trial within on month prior to this study
  • pregnancy or brest feeding
  • septic shock
  • interference with cystatin-C

    1. haemolysis <1g/dl
    2. Bilirubin<9mg/dl
    3. Triglyceride >700mg/dl
    4. rheumatoid factor > 300kIU/l
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308073


Locations
Germany
Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf
Duesseldorf, Germany, 40225
Sponsors and Collaborators
Klinik für Anästhesiologie
Fresenius Medical Care Deutschland GmbH
Investigators
Principal Investigator: Detlef Kindgen-Milles, Prof. Klinik für Anästhesiologie Universitätsklinikum Düsseldorf Heinrich-Heine Universität
  More Information

Responsible Party: Klinik für Anästhesiologie, Leiter Interdisziplinäre Operative Intensivstation ZOM-I, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT01308073     History of Changes
Other Study ID Numbers: EMIC2_2011_02_03
First Submitted: February 4, 2011
First Posted: March 3, 2011
Last Update Posted: December 19, 2014
Last Verified: December 2014