Stability of Middle Molecule Clearance
EMIC2
Long-time Stability of Middle Molecule Clearance During CI-Ca CVVHD
1 other identifier
observational
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedDecember 19, 2014
December 1, 2014
3.7 years
February 4, 2011
December 18, 2014
Conditions
Outcome Measures
Primary Outcomes (7)
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 Outcomes (3)
Mean arterial pressure
up to 72 h
Vasopressor requirement
up to 72 h
Heart rate
up to 72 h
Study Arms (1)
EMIC 2 dialysis
Patients on ICU requiring dialysis for acute renal insufficiency
Interventions
Patients with indication for routine continuous hemodialysis due to acute renal insufficiency
Eligibility Criteria
Patients of surgical intensive care unit
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf
Düsseldorf, 40225, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Detlef Kindgen-Milles, Prof.
Klinik für Anästhesiologie Universitätsklinikum Düsseldorf Heinrich-Heine Universität
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Leiter Interdisziplinäre Operative Intensivstation ZOM-I
Study Record Dates
First Submitted
February 4, 2011
First Posted
March 3, 2011
Study Start
March 1, 2011
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
December 19, 2014
Record last verified: 2014-12