title: Post-ICU discharge and outcome: rationale and methods of the The French and euRopean Outcome reGistry in Intensive Care Units (FROG-ICU) observational study.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01367093 .
authors.affiliation: Department of Anesthesiology and Intensive Care, Saint Louis - Lariboisière - Fernand Widal University Hospital, AP-HP, Paris, France. alexandre.mebazaa@lrb.aphp.fr.|INSERM UMR-S 942, Paris, France. alexandre.mebazaa@lrb.aphp.fr.|Department of Anesthesiology and Critical Care Medicine, Saint Louis - Lariboisière University Hospital, University Paris Diderot, UMR-S 942, INSERM, 2 rue Ambroise Paré, 75010, Paris, France. alexandre.mebazaa@lrb.aphp.fr.|DHU Neurovasculaire, Paris, France. alexandre.mebazaa@lrb.aphp.fr.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Mebazaa
authors.affiliation: Department of Anesthesiology and Intensive Care, Saint Louis - Lariboisière - Fernand Widal University Hospital, AP-HP, Paris, France.|INSERM UMR-S 942, Paris, France.|Department of Anesthesiology and Critical Care Medicine, Saint Louis - Lariboisière University Hospital, University Paris Diderot, UMR-S 942, INSERM, 2 rue Ambroise Paré, 75010, Paris, France.
authors.forename: Maria Chiara
authors.initials: MC
authors.lastname: Casadio
authors.affiliation: Medical intensive care, Saint Louis - Lariboisière - Fernand Widal University Hospital, AP-HP, Paris, France.|INSERM UMR-S 717, Paris, France.
authors.forename: Elie
authors.initials: E
authors.lastname: Azoulay
authors.affiliation: Medical intensive care, Saint Antoine University Hospital, AP-HP, Paris, France.|INSERM UMR 1136, Paris, France.|University Paris VI, Paris, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Guidet
authors.affiliation: Surgical Intensive Care, Saint Eloi University Hospital, Montpellier, France.
authors.forename: Samir
authors.initials: S
authors.lastname: Jaber
authors.affiliation: Medical intensive care, CHU Nancy - Hôpital Brabois Adultes, Vandœuvre-les-Nancy, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Levy
authors.affiliation: Department of Anesthesiology and Intensive Care, Saint Louis - Lariboisière - Fernand Widal University Hospital, AP-HP, Paris, France.|Department of Anesthesiology and Critical Care Medicine, Saint Louis - Lariboisière University Hospital, University Paris Diderot, UMR-S 942, INSERM, 2 rue Ambroise Paré, 75010, Paris, France.|INSERM UMR-S 1160, Paris, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Payen
authors.affiliation: INSERM UMR-S 942, Paris, France.|Department of Anesthesiology and Critical Care Medicine, Saint Louis - Lariboisière University Hospital, University Paris Diderot, UMR-S 942, INSERM, 2 rue Ambroise Paré, 75010, Paris, France.|Unité de Recherche Clinique, Saint Louis - Lariboisière - Fernand Widal University Hospital, AP-HP, Paris, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Vicaut
authors.affiliation: INSERM UMR-S 717, Paris, France.|Service de Biostatistique et d'Informatique Médicale, Saint Louis - Lariboisière - Fernand Widal University Hospital, AP-HP, Paris, France.
authors.forename: Matthieu
authors.initials: M
authors.lastname: Resche-Rigon
authors.affiliation: Department of Anesthesiology and Intensive Care, Saint Louis - Lariboisière - Fernand Widal University Hospital, AP-HP, Paris, France.|INSERM UMR-S 942, Paris, France.|Department of Anesthesiology and Critical Care Medicine, Saint Louis - Lariboisière University Hospital, University Paris Diderot, UMR-S 942, INSERM, 2 rue Ambroise Paré, 75010, Paris, France.
authors.forename: Etienne
authors.initials: E
authors.lastname: Gayat
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D015331:Cohort Studies; D005060:Europe / Q000453:epidemiology; D005500:Follow-Up Studies; D005602:France / Q000453:epidemiology; D007362:Intensive Care Units / Q000639:trends; D009026:Mortality / Q000639:trends; D010351:Patient Discharge / Q000639:trends; D011446:Prospective Studies; D012042:Registries; D016896:Treatment Outcome; D015337:Multicenter Studies as Topic; D064887:Observational Studies as Topic