Stability of Middle Molecule Clearance (EMIC2)

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.

Study Overview

• Status: Completed
• Conditions: Continuous Hemodialysis
• Intervention / Treatment: Device: Hemodialysis with EMIC 2 filters

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Germany
  • Duesseldorf, Germany, 40225
    • Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of surgical intensive care unit

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean arterial pressure	up to 72 h
Vasopressor requirement	up to 72 h
Heart rate	up to 72 h

Collaborators and Investigators

• Sponsor: Klinik für Anästhesiologie
• Collaborators: Fresenius Medical Care Deutschland GmbH
• Investigators: Principal Investigator: Detlef Kindgen-Milles, Prof., Klinik für Anästhesiologie Universitätsklinikum Düsseldorf Heinrich-Heine Universität

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: March 2, 2011
• First Posted (Estimate): March 3, 2011

Study Record Updates

• Last Update Posted (Estimate): December 19, 2014
• Last Update Submitted That Met QC Criteria: December 18, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: EMIC2_2011_02_03