Stability of Middle Molecule Clearance (EMIC2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Heinrich-Heine University, Duesseldorf
Sponsor:
Collaborator:
Fresenius Medical Care Deutschland GmbH
Information provided by (Responsible Party):
Klinik für Anästhesiologie, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier:
NCT01308073
First received: February 4, 2011
Last updated: March 26, 2014
Last verified: March 2014
  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 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 ]

Estimated Enrollment: 15
Study Start Date: March 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: September 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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308073

Contacts
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

Locations
Germany
Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf Recruiting
Duesseldorf, Germany, 40225
Contact: Kindgen-Milles    +49 211 81 ext 07049      
Principal Investigator: Detlef Kindgen-Milles, Prof.         
Sub-Investigator: Robert Kalb, Dr. med.         
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

No publications provided

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
Study First Received: February 4, 2011
Last Updated: March 26, 2014
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on July 29, 2014