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OpenTrials
Completed

NCT Number: NCT01308073

Stability of Middle Molecule Clearance

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

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Key information

Conditions

Continuous Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf

Düsseldorf, 40225, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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
  • haemolysis <1g/dl
  • Bilirubin<9mg/dl
  • Triglyceride >700mg/dl
  • rheumatoid factor > 300kIU/l

Treatment and study plan

Hemodialysis with EMIC 2 filters

Device

Patients with indication for routine continuous hemodialysis due to acute renal insufficiency

Primary outcomes

  1. Clearance of Urea

    Time frame: up to 72 h

  2. Clearance of Cystatin C

    Time frame: up to 72 h

  3. Clearance of creatinine

    Time frame: up to 72 h

  4. Clearance of Beta2-Microglobulin

    Time frame: up to 72 h

  5. Clearance of Osteocalcin

    Time frame: up to 72 h

  6. Free light chains kappa of Immunoglobulins

    Time frame: up to 72 h

  7. Clearance of albumin

    Time frame: up to 72 h

Secondary outcomes

  1. Mean arterial pressure

    Time frame: up to 72 h

  2. Vasopressor requirement

    Time frame: up to 72 h

  3. Heart rate

    Time frame: up to 72 h

Sponsors and collaborators

Lead sponsor

Klinik für Anästhesiologie

Other

Collaborators

  • Fresenius Medical Care Deutschland GmbH

Registry information

Official study title

Long-time Stability of Middle Molecule Clearance During CI-Ca CVVHD

Acronym: EMIC2

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 3, 2011
Registry last updated
Dec 19, 2014

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.