Intensive Care - GLObal Study on Severe Acute Respiratory Infection
Intensive Care - GLObal Study on Severe Acute Respiratory Infection
IC-GLOSSARI (The Intensive Care GLObal Study on Severe Acute Respiratory Infection) is a
 multicentre, prospective, observational,14-day inception cohort study designed and conducted
 by the ESICM Trials Group to investigate the epidemiology and microbiology profiles of
 ICU-SARI, document commonly used treatment and monitoring strategies, measure current
 outcomes and identify potential topics for multidisciplinary studies ranging from
 interventional clinical trials to fundamental mechanisms of disease.

 The purpose of this study is to answer the following questions:

 What is the frequency and disease burden of SARI for ICU's worldwide? What are the
 aetiologies of ICU SARI? How are SARI patients diagnosed and managed in the ICU? What is the
 outcome from SARI in the ICU? Is there a difference in outcomes from SARI depending on the
 aetiology of the disease? Can we identify high-risk categories of SARI that could constitute
 a defined population for an interventional study?
Following the recent outbreaks of SARS and H1N1 influenza infections, there has been a
 significant interest in the surveillance of patients with severe acute respiratory infections
 (SARI), defined by the World Health Organisation (WHO) as an acute respiratory illness of
 recent onset (within 7 days) manifested by fever (≥ 38°C), cough, and dyspnea requiring
 overnight hospitalization.

 Whereas this definition of SARI may prove practical to mount sentinel SARI surveillance
 systems, it is unlikely to provide relevant information for intensive care physicians
 regarding the nature of infections, the spectrum of severity, or the diagnostic and treatment
 strategies used for the subset of patients that are ultimately admitted to intensive care
 units. Only a subset of the SARI patients as defined by WHO will require ICU admission for
 oxygen therapy or positive pressure ventilation; a smaller subset will develop an acute
 respiratory distress syndrome (ARDS) and an even smaller proportion will require adjunctive
 treatments such as nitric oxide, ECMO, use of prone position or high frequency oscillation
 (HFO). Obtaining accurate information on the epidemiology of ICU-SARI and how these patients
 are currently diagnosed and treated will help us to understand the factors associated with
 progression from acute respiratory infections to the most severe forms of critical illness
 such as ARDS, septic shock, or multiple organ failure.

 We thus aim to undertake a prospective, observational, inception cohort study to investigate
 the epidemiology and microbiology profiles of ICU-SARI, document commonly used treatment and
 monitoring strategies, measure current outcomes and identify potential topics for
 multidisciplinary studies ranging from interventional clinical trials to fundamental
 mechanisms of disease.

 Fourteen day international inception cohort study of adult (≥18 years) patients presenting
 with SARI on admission to the ICU (ICU-SARI).

 The study will be performed over 4 weeks. Each centre will include patients for 2 weeks, one
 in November and the other in January.

 First week: 3 - 9 Nov 2013

 Second week: 10-17 Nov 2013

 Third week: 13-19 Jan 2014

 Fourth week: 20-26 Jan 2014

 To be eligible patients must have ICU-SARI as defined by the following

 1. Admitted to an Intensive Care Unit due to respiratory tract infection

 2. Recent onset (within 7 days prior to ICU admission) of at least one of the following
 manifestations:

 -  Dyspnea

 -  Fever (≥ 38°C)

 -  Possible, probable or microbiologically confirmed respiratory tract infection

 The following will be excluded from the study:

 Patients less than 18 years of age Patients in whom the pneumonia cough and dyspnoea have
 been present for over seven days Any patients who are on invasive (through an endotracheal
 tube) mechanical ventilation prior to admission for any reason other than general anaesthesia
 for surgical procedures.

 Any patients previously included in the study during the same study period Data collection
 will start on admission to the ICU and will continue on a daily basis in the ICU for a
 maximum of 28 days. The vital status at day 60 will be recorded (discharge, alive in the ICU,
 dead) so long as the patients is still hospitalized.

 For a subgroup of investigator on a voluntary basis, the end-point will be extended to day 90
 and day 180.

 This international study aims to recruit as many centres as possible. A network of national
 coordinators will be identified. It will be the task of this group of individuals to enrol
 sites within their own country, to ensure the necessary regulatory approvals are in place and
 to coordinate the national communication.

 ICU will be defined as a unit able to provide positive pressure ventilation and continuous
 monitoring of hemodynamic and respiratory variables. Recruitment of participating ICUs will
 be done through advertising of the study to ICUs registered in the ERIC; ICUs registered in
 the ESICM databases (membership & congresses, H1N1 registry, EuSOS, Euro-BACT; ICUs
 registered in SAPS 3; ICUs registered in VENTILA.

 We also plan to seek participation from ICUs of other research networks that may be
 interested in a joint research effort on this topic (Sepnet, Capnetz, GiVITI, ICNARC, CCCTG,
 ANZICS, SPCI).Through a study specific web site. And through advertising at National and
 international meetings.
Inclusion Criteria:

 -  Admitted to an Intensive Care Unit due to respiratory tract infection

 -  Recent onset (within 7 days prior to ICU admission) of at least one of the following
 manifestations: dyspnea, fever (≥ 38°C, possible, probable or microbiologically
 confirmed respiratory tract infection

 Exclusion Criteria:

 -  Patients less than 18 years of age

 -  Patients in whom the pneumonia cough and dyspnoea have been present for over seven
 days

 -  Any patients who are on invasive (through an endotracheal tube) mechanical ventilation
 prior to admission for any reason other than general anaesthesia for surgical
 procedures.

 -  Any patients previously included in the study during the same study period