Stability of Middle Molecule Clearance (EMIC2)

This study is currently recruiting participants.
Verified March 2012 by Heinrich-Heine University, Duesseldorf
Sponsor:
Collaborator:
Fresenius Medical Care North America
Information provided by (Responsible Party):
Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01308073
First received: February 4, 2011
Last updated: March 15, 2012
Last verified: March 2012

February 4, 2011
March 15, 2012
March 2011
December 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01308073 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Stability of Middle Molecule Clearance
Long-time Stability of Middle Molecule Clearance During CI-Ca CVVHD

The investigators aim to show, whether all middle molecules are included in the clearance and whether this clearance is stable until 72 hours.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients of surgical intensive care unit

Continuous Hemodialysis
Device: Hemodialysis with EMIC 2 filters
Patients with indication for routine continuous hemodialysis due to acute renal insufficiency
EMIC 2 dialysis
Patients on ICU requiring dialysis for acute renal insufficiency
Intervention: Device: Hemodialysis with EMIC 2 filters
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Detlef Kindgen-Milles, Prof. +49 211 81 ext 07047 kindgen-milles@med.uni-duesseldorf.de
Contact: Kalb Robert, Dr. med. +49 211 81 ext 18101 Robert.kalb@med.uni-duesseldorf.de
Germany
 
NCT01308073
EMIC2_2011_02_03
No
Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
Klinik für Anästhesiologie
Fresenius Medical Care North America
Principal Investigator: Detlef Kindgen-Milles, Prof. Klinik für Anästhesiologie Universitätsklinikum Düsseldorf Heinrich-Heine Universität
Heinrich-Heine University, Duesseldorf
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP