ESICM
ESICM aims to foster collaborative research among its members and to promote European Intensive Care Research. There are several clinical trials currently under discussion and for which several meetings have already been organised. Here is a list of some of the projects that are ongoing and at different stages of development.
LUNG-SAFE - Large observational study to UNderstand the Global impact of Severe Acute respiratory FailurE is a multicentre, prospective, observational, 4-week inception cohort study being carried out by the Acute Respiratory Failure section of ESICM. The aim is to prospectively assess the burden of, management and therapeutic approaches to, and outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the winter months in both the northern and southern hemispheres. This study will specifically examine the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic respiratory failure.
IC-GLOSSARI – Intensive Care - GLObal Study on Severe Acute Respiratory Infection. Yasser Sakr is the principal investigator of this multi-centre, international fourteen-day inception cohort study of severe acute respiratory infections in intensive care units.
SDD – Selective Decontamination of the Digestive Tract. This study is under the leadership of the Utrecht team including Jozef Kesecioglu. A survey has been completed and the results were discussed at a meeting in August in Brussels. A draft protocol is under discussion and revision. In this study, the aim is to test whether a cluster application of SDD, irrespective of baseline antimicrobial resistance rates, will decrease mortality without an increase of antimicrobial resistance rate in the ICU.
DALI– Defining Antibiotic Levels in Intensive Care Patients.
This study is under the leadership of Jeffrey Lipman. The principal aim is to determine whether contemporary antibiotic dosing for critically-ill patients is achieving concentrations associated with maximal acitivity
FENICE– Fluid ChallENges in Intensive CarE. This trial is under the leadership of Daniel De Backer and Maurizio Cecconi.
The aim is to conduct a large scale multicentric observational trial conducted by the ECCRN Trial Group and the ESICM Cardiovascular Section to identify which variables are used by physicians to trigger/indicate/guide fluid administration in critically-ill patients.
• Understanding how fluids are administered in critically-ill patients will provide vital information, allowing us to characterise one of the most common procedures we perform every day.
• All consecutive patients, up to a maximum of 20 for each centre, in whom a fluid challenge is performed during a one week period (either APRIL 17 to APRIL 23 or MAY 23 to MAY 29, 2013 to be selected by investigators according to what fits best with local organisation) will be included. The amount of collected data for each patient will be relatively limited.
EUSOS– European Surgical Outcomes Study (EuSOS). Mortality after Surgery in Europe. This was a joint study between ESICM- the European Society of Intensive Care and ESA- the European Society of Anaesthesiology. The results of this 7-day cohort study under the leadership of Rupert Pearce have been published in the Lancet.
Pallicus– Under the leadership of Elie Azoulay. The aim is to set-up a 3-network study (ESICM, REVA and FAMIREA); a prospective, non interventional, multicentre cohort study. According to the number of participating ICUs, the study was a one-day study (300 ICUs), a one-week study (100 ICUs) or a 2-week study. Date of start: Winter 2012.
Cars– Under the leadership of Djillali Annane. The aim is to set-up a phase III randomised, placebo-controlled, double-Blind clinical trial to Evaluate the Safety and Efficacy of Low-Dose Hydrocortisone in Subjects with Early Acute Respiratory Distress Syndrome.