Post-ICU discharge and outcome: rationale and methods of the The French and euRopean Outcome reGistry in Intensive Care Units (FROG-ICU) observational study

BACKGROUND: Previous studies have demonstrated that ICU (intensive care unit) survivors have decreased long-term survival rates compared to the general population. However, knowledge about how to identify ICU survivors with higher risk of death and the adjustable factors associated with mortality is still lacking. METHODS AND DESIGN: The FROG-ICU (the French and European Outcome Registry in Intensive Care Units) study is a prospective, observational, multicenter cohort study where ICU survivors are followed up to one year after ICU discharge. Beside one year survival, the study is designed to assess incidence and identifying risk factors for mortality over the year following discharge from the ICU. All consecutive patients admitted in ICU to the 28 participating centers during the study period will be included. Every subject will undergo an evaluation at admission, throughout the ICU stay and at ICU discharge. The global, especially cardiovascular, assessment of each subject will be performed through a complete clinical exam, instrumental tests (electrocardiogram, echocardiogram) and biological parameters. Blood and urine samples will be collected at admission and at discharge with the primary goal to assess effectiveness of routine and novel cardiovascular, inflammatory and renal biomarkers, with potential interest in risk stratification for patients who survive an ICU stay. The follow up will include a careful tracking of patients through telephone calls and questionnaires at 3, 6 and 12 months after ICU discharge. FROG-ICU aims to identify the clinical and biological phenotype of patients with different levels of probability of death in the year after ICU discharge. DISCUSSION: FROG-ICU has been designed to better understand long term outcome after ICU discharge as well as risk factors for all-cause and cardiovascular morbidity and associated mortality. It is a large prospective multicenter cohort with a biological (on plasma and urine) collection and one-year follow-up of ICU patients. FROG ICU will allow performing a risk stratification of ICU survivors as to recognize the subset of patients who may benefit from an early intervention to allow decreased cardiovascular morbidity and related mortality. TRIAL REGISTRATION: ClinicalTrials.gov NCT01367093.