Stability of Middle Molecule Clearance

Completed

• Conditions: Continuous Hemodialysis
• Interventions: Device: Hemodialysis with EMIC 2 filters

• Registration Number: NCT01308073
• Lead Sponsor: Klinik für Anästhesiologie

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2011-02-04
• Study Start: 2011-03
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-03
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EMIC 2 dialysis	Hemodialysis with EMIC 2 filters	Patients on ICU requiring dialysis for acute renal insufficiency

Primary Outcome Measures

Name	Time	Method
Clearance of Cystatin C	up to 72 h
Clearance of creatinine	up to 72 h
Clearance of Urea	up to 72 h
Clearance of albumin	up to 72 h
Clearance of Beta2-Microglobulin	up to 72 h
Free light chains kappa of Immunoglobulins	up to 72 h
Clearance of Osteocalcin	up to 72 h

Secondary Outcome Measures

Name	Time	Method
Mean arterial pressure	up to 72 h
Heart rate	up to 72 h
Vasopressor requirement	up to 72 h

Trial Locations

Locations (1)

Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf; 🇩🇪 Duesseldorf, Germany