Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Stability of Middle Molecule Clearance (EMIC2)

This study has been completed.
Fresenius Medical Care Deutschland GmbH
Information provided by (Responsible Party):
Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf Identifier:
First received: February 4, 2011
Last updated: December 18, 2014
Last verified: December 2014

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 Heinrich-Heine University, Duesseldorf:

Primary Outcome Measures:
  • Clearance of Urea [ Time Frame: up to 72 h ] [ Designated as safety issue: No ]
  • Clearance of Cystatin C [ Time Frame: up to 72 h ] [ Designated as safety issue: No ]
  • Clearance of creatinine [ Time Frame: up to 72 h ] [ Designated as safety issue: No ]
  • Clearance of Beta2-Microglobulin [ Time Frame: up to 72 h ] [ Designated as safety issue: No ]
  • Clearance of Osteocalcin [ Time Frame: up to 72 h ] [ Designated as safety issue: No ]
  • Free light chains kappa of Immunoglobulins [ Time Frame: up to 72 h ] [ Designated as safety issue: No ]
  • Clearance of albumin [ Time Frame: up to 72 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean arterial pressure [ Time Frame: up to 72 h ] [ Designated as safety issue: No ]
  • Vasopressor requirement [ Time Frame: up to 72 h ] [ Designated as safety issue: No ]
  • Heart rate [ Time Frame: up to 72 h ] [ Designated as safety issue: No ]

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of surgical intensive care unit


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
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Please refer to this study by its identifier: NCT01308073

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

No publications provided

Responsible Party: Klinik für Anästhesiologie, Leiter Interdisziplinäre Operative Intensivstation ZOM-I, Heinrich-Heine University, Duesseldorf Identifier: NCT01308073     History of Changes
Other Study ID Numbers: EMIC2_2011_02_03
Study First Received: February 4, 2011
Last Updated: December 18, 2014
Health Authority: Germany: Ethics Commission processed this record on March 03, 2015