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Stability of Middle Molecule Clearance

NCT ID: NCT01308073

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-11-30

Brief Summary

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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

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

Conditions

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Continuous Hemodialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EMIC 2 dialysis

Patients on ICU requiring dialysis for acute renal insufficiency

Hemodialysis with EMIC 2 filters

Intervention Type DEVICE

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

Interventions

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Hemodialysis with EMIC 2 filters

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role collaborator

Klinik für Anästhesiologie

OTHER

Sponsor Role lead

Responsible Party

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Klinik für Anästhesiologie

Leiter Interdisziplinäre Operative Intensivstation ZOM-I

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Detlef Kindgen-Milles, Prof.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anästhesiologie Universitätsklinikum Düsseldorf Heinrich-Heine Universität

Locations

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Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EMIC2_2011_02_03

Identifier Type: -

Identifier Source: org_study_id