In-line Filters on ICU

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.

Study Overview

• Status: Completed
• Conditions: Micropore Filters

• Study Type: Observational
• Enrollment (Actual): 3281

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

• all patients

Exclusion Criteria:

• Younger than 18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of severe vasoplegia	participants will be followed for the duration of intensive care unit stay, an expected average of 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Organ dysfunction	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	participants will be followed for the duration of intensive care unit stay, an expected average of 1 week
Inflammation	Interleukin-6	participants will be followed for the duration of intensive care unit stay, an expected average of 1 week
Duration of ICU and hospital stay		participants will be followed for the duration of intensive care unit/ hospital stay, an expected average of 1 or 4 week (s), respectively
In-hospital mortality		participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Morbidity	Incidence of preoperative myocardial infarction, stroke, pneumonia, sepsis and acute kidney failure according to routine documentation	participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital
• Investigators: Principal Investigator: Kai Zacharowski, M.D., University Hospital Frankfurt. Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy.

Publications and helpful links

General Publications

• Schmitt E, Meybohm P, Herrmann E, Ammersbach K, Endres R, Lindau S, Helmer P, Zacharowski K, Neb H. In-line filtration of intravenous infusion may reduce organ dysfunction of adult critical patients. Crit Care. 2019 Nov 22;23(1):373. doi: 10.1186/s13054-019-2618-z.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: October 30, 2014
• First Posted (Estimate): November 2, 2014

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: In-line Filter 13/14