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In-line Filters on ICU

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ClinicalTrials.gov Identifier: NCT02281604
Recruitment Status : Completed
First Posted : November 2, 2014
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Kai Zacharowski, M.D., Ph.D., FRCA, Johann Wolfgang Goethe University Hospital

Brief Summary:
The purpose of this study is to determine whether the use of 0.2/1.2 microliter in-line filter reduces the incidence of severe vasoplegia comparing to the 5 microliter filter.

Condition or disease
Micropore Filters

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Study Type : Observational
Actual Enrollment : 3281 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : December 2018

Group/Cohort
0.2/1.2 microliter filter
Use of 0.2/1.2 microliter filters for intravenous drug administration
5 mircroliter filter
Use of 5 microliter filters for intravenous drug administration



Primary Outcome Measures :
  1. Incidence of severe vasoplegia [ Time Frame: participants will be followed for the duration of intensive care unit stay, an expected average of 1 week ]

Secondary Outcome Measures :
  1. Organ dysfunction [ Time Frame: participants will be followed for the duration of intensive care unit stay, an expected average of 1 week ]
    Severity of organdysfunction (SOFA-Score), incidence and severity of respiratory failure (Horovitz- Index), incidence and severity of acute kidney failure (RIFLE criteria), incidence and severity of delirium

  2. Inflammation [ Time Frame: participants will be followed for the duration of intensive care unit stay, an expected average of 1 week ]
    Interleukin-6

  3. Duration of ICU and hospital stay [ Time Frame: participants will be followed for the duration of intensive care unit/ hospital stay, an expected average of 1 or 4 week (s), respectively ]
  4. In-hospital mortality [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
  5. Morbidity [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks ]
    Incidence of preoperative myocardial infarction, stroke, pneumonia, sepsis and acute kidney failure according to routine documentation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients, which will be treated on the anaesthesiological/surgical ICU of the University Hospital Frankfurt between 2013 - 2014
Criteria

Inclusion Criteria:

  • all patients

Exclusion Criteria:

  • Younger than 18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281604


Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Principal Investigator: Kai Zacharowski, M.D. University Hospital Frankfurt. Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Kai Zacharowski, M.D., Ph.D., FRCA, Prof. Dr. Dr. med., Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT02281604    
Other Study ID Numbers: In-line Filter 13/14
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019