期刊论文详细信息
BMC Anesthesiology
Post-ICU discharge and outcome: rationale and methods of the The French and euRopean Outcome reGistry in Intensive Care Units (FROG-ICU) observational study
Alexandre Mebazaa1  Maria Chiara Casadio6  Elie Azoulay3  Bertrand Guidet2  Samir Jaber5  Bruno Levy4  Didier Payen6  Eric Vicaut6  Matthieu Resche-Rigon3  Etienne Gayat6 
[1] DHU Neurovasculaire, Paris, France
[2] University Paris VI, Paris, France
[3] INSERM UMR-S 717, Paris, France
[4] Medical intensive care, CHU Nancy - Hôpital Brabois Adultes, Vandœuvre-les-Nancy, France
[5] Surgical Intensive Care, Saint Eloi University Hospital, Montpellier, France
[6] Department of Anesthesiology and Critical Care Medicine, Saint Louis – Lariboisière University Hospital, University Paris Diderot, UMR-S 942, INSERM, 2 rue Ambroise Paré, Paris, 75010, France
关键词: Biomarkers;    Mortality;    Outcome;    Intensive care unit;   
Others  :  1228352
DOI  :  10.1186/s12871-015-0129-2
 received in 2014-11-07, accepted in 2015-10-06,  发布年份 2015
PDF
【 摘 要 】

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.

【 授权许可】

   
2015 Mebazaa et al.

【 预 览 】
附件列表
Files Size Format View
20151016002208155.html 180KB HTML download
Fig. 1. 17KB Image download
【 图 表 】

Fig. 1.

【 参考文献 】
  • [1]Turnbull AD, Carlon G, Baron R, Sichel W, Young C, Howland W. The inverse relationship between cost and survival in the critically ill cancer patient. Crit Care Med. 1979; 7(1):20-3.
  • [2]Spagnolo SV, Hershberg PI, Zimmerman HJ. Medical intensive care unit. Mortality rate experience in large teaching hospital. N Y State J Med. 1973; 73(6):754-7.
  • [3]Dowdy DW, Eid MP, Sedrakyan A, Mendez-Tellez PA, Pronovost PJ, Herridge MS et al.. Quality of life in adult survivors of critical illness: a systematic review of the literature. Intensive Care Med. 2005; 31(5):611-20.
  • [4]Harrison DA, Brady AR, Rowan K. Case mix, outcome and length of stay for admissions to adult, general critical care units in England, Wales and Northern Ireland: the intensive care national audit & research centre case Mix programme database. Crit Care. 2004; 8(2):R99-111. BioMed Central Full Text
  • [5]Boumendil A, Angus DC, Guitonneau AL, Menn AM, Ginsburg C, Takun K et al.. Variability of intensive care admission decisions for the very elderly. PLoS One. 2012; 7(4): Article ID e34387
  • [6]Boumendil A, Latouche A, Guidet B. On the benefit of intensive care for very old patients. Arch Intern Med. 2011; 171(12):1116-7.
  • [7]Brun-Buisson C, Doyon F, Carlet J, Dellamonica P, Gouin F, Lepoutre A et al.. Incidence, risk factors, and outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units. French ICU Group for Severe Sepsis. JAMA. 1995; 274(12):968-74.
  • [8]Friedman G, Silva E, Vincent JL. Has the mortality of septic shock changed with time. Crit Care Med. 1998; 26(12):2078-86.
  • [9]Desai SV, Law TJ, Needham DM. Long-term complications of critical care. Crit Care Med. 2011; 39(2):371-9.
  • [10]Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H et al.. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012; 40(2):502-9.
  • [11]Niskanen M, Kari A, Halonen P. Five-year survival after intensive care--comparison of 12,180 patients with the general population. Finnish ICU Study Group. Crit Care Med. 1996; 24(12):1962-7.
  • [12]Flaatten H, Kvale R. Survival and quality of life 12 years after ICU. A comparison with the general Norwegian population. Intensive Care Med. 2001; 27(6):1005-11.
  • [13]Wright JC, Plenderleith L, Ridley SA. Long-term survival following intensive care: subgroup analysis and comparison with the general population. Anaesthesia. 2003; 58(7):637-42.
  • [14]Cuthbertson BH, Rattray J, Campbell MK, Gager M, Roughton S, Smith A et al.. The PRaCTICaL study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial. BMJ. 2009; 339:b3723.
  • [15]Williams TA, Dobb GJ, Finn JC, Knuiman MW, Geelhoed E, Lee KY et al.. Determinants of long-term survival after intensive care. Crit Care Med. 2008; 36(5):1523-30.
  • [16]Hofhuis JG, Spronk PE, van Stel HF, Schrijvers GJ, Rommes JH, Bakker J. The impact of critical illness on perceived health-related quality of life during ICU treatment, hospital stay, and after hospital discharge: a long-term follow-up study. Chest. 2008; 133(2):377-85.
  • [17]Zaren B, Bergstrom R. Survival of intensive care patients. I: Prognostic factors from the patient's medical history. Acta Anaesthesiol Scand. 1988; 32(2):93-100.
  • [18]Dragsted L, Qvist J. Outcome from intensive care. III. A 5-year study of 1308 patients: activity levels. Eur J Anaesthesiol. 1989; 6(5):385-96.
  • [19]Rockwood K, Noseworthy TW, Gibney RT, Konopad E, Shustack A, Stollery D et al.. One-year outcome of elderly and young patients admitted to intensive care units. Crit Care Med. 1993; 21(5):687-91.
  • [20]Douglas SL, Daly BJ, Gordon N, Brennan PF. Survival and quality of life: short-term versus long-term ventilator patients. Crit Care Med. 2002; 30(12):2655-62.
  • [21]Keenan SP, Dodek P, Chan K, Hogg RS, Craib KJ, Anis AH et al.. Intensive care unit admission has minimal impact on long-term mortality. Crit Care Med. 2002; 30(3):501-7.
  • [22]Kaarlola A, Pettila V, Kekki P. Quality of life six years after intensive care. Intensive Care Med. 2003; 29(8):1294-9.
  • [23]Bagshaw SM, Mortis G, Doig CJ, Godinez-Luna T, Fick GH, Laupland KB. One-year mortality in critically ill patients by severity of kidney dysfunction: a population-based assessment. Am J Kidney Dis. 2006; 48(3):402-9.
  • [24]Orwelius L, Nordlund A, Nordlund P, Simonsson E, Backman C, Samuelsson A et al.. Pre-existing disease: the most important factor for health related quality of life long-term after critical illness: a prospective, longitudinal, multicentre trial. Crit Care. 2010; 14(2):R67. BioMed Central Full Text
  • [25]Braun A, Chang D, Mahadevappa K, Gibbons FK, Liu Y, Giovannucci E et al.. Association of low serum 25-hydroxyvitamin D levels and mortality in the critically ill. Crit Care Med. 2011; 39(4):671-7.
  • [26]Meynaar IA, Van Den Boogaard M, Tangkau PL, Dawson L, Sleeswijk Visser S, Bakker J. Long-term survival after ICU treatment. Minerva Anestesiol. 2012; 78(12):1324-32.
  • [27]Grander W, Mullauer K, Koller B, Tilg H, Dunser M. Heart rate before ICU discharge: a simple and readily available predictor of short- and long-term mortality from critical illness. Clin Res Cardiol. 2013; 102(8):599-606.
  • [28]Luangasanatip N, Hongsuwan M, Lubell Y, Limmathurotsakul D, Teparrukkul P, Chaowarat S et al.. Long-term survival after intensive care unit discharge in Thailand: a retrospective study. Crit Care. 2013; 17(5):R219. BioMed Central Full Text
  • [29]Lim W, Qushmaq I, Cook DJ, Crowther MA, Heels-Ansdell D, Devereaux PJ. Elevated troponin and myocardial infarction in the intensive care unit: a prospective study. Crit Care. 2005; 9(6):R636-44. BioMed Central Full Text
  • [30]Lim W, Cook DJ, Griffith LE, Crowther MA, Devereaux PJ. Elevated cardiac troponin levels in critically ill patients: prevalence, incidence, and outcomes. Am J Crit Care. 2006; 15(3):280-8.
  • [31]Martin M, Mullenix P, Rhee P, Belzberg H, Demetriades D, Salim A. Troponin increases in the critically injured patient: mechanical trauma or physiologic stress? J Trauma. 2005; 59(5):1086-91.
  • [32]Quenot JP, Le Teuff G, Quantin C, Doise JM, Abrahamowicz M, Masson D et al.. Myocardial injury in critically ill patients: relation to increased cardiac troponin I and hospital mortality. Chest. 2005; 128(4):2758-64.
  • [33]King DA, Codish S, Novack V, Barski L, Almog Y. The role of cardiac troponin I as a prognosticator in critically ill medical patients: a prospective observational cohort study. Crit Care. 2005; 9(4):R390-5. BioMed Central Full Text
  • [34]Landesberg G, Vesselov Y, Einav S, Goodman S, Sprung CL, Weissman C. Myocardial ischemia, cardiac troponin, and long-term survival of high-cardiac risk critically ill intensive care unit patients. Crit Care Med. 2005; 33(6):1281-7.
  • [35]Wu TT, Yuan A, Chen CY, Chen WJ, Luh KT, Kuo SH et al.. Cardiac troponin I levels are a risk factor for mortality and multiple organ failure in noncardiac critically ill patients and have an additive effect to the APACHE II score in outcome prediction. Shock. 2004; 22(2):95-101.
  • [36]Baillard C, Boussarsar M, Fosse JP, Girou E, Le Toumelin P, Cracco C et al.. Cardiac troponin I in patients with severe exacerbation of chronic obstructive pulmonary disease. Intensive Care Med. 2003; 29(4):584-9.
  • [37]Logeart D, Thabut G, Jourdain P, Chavelas C, Beyne P, Beauvais F et al.. Predischarge B-type natriuretic peptide assay for identifying patients at high risk of re-admission after decompensated heart failure. J Am Coll Cardiol. 2004; 43(4):635-41.
  • [38]Cohen-Solal A, Logeart D, Huang B, Cai D, Nieminen MS, Mebazaa A. Lowered B-type natriuretic peptide in response to levosimendan or dobutamine treatment is associated with improved survival in patients with severe acutely decompensated heart failure. J Am Coll Cardiol. 2009; 53(25):2343-8.
  • [39]Ueda S, Nishio K, Akai Y, Fukushima H, Ueyama T, Kawai Y et al.. Prognostic value of increased plasma levels of brain natriuretic peptide in patients with septic shock. Shock. 2006; 26(2):134-9.
  • [40]Post F, Weilemann LS, Messow CM, Sinning C, Munzel T. B-type natriuretic peptide as a marker for sepsis-induced myocardial depression in intensive care patients. Crit Care Med. 2008; 36(11):3030-7.
  • [41]Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM, Kastelein JJ et al.. Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet. 2009; 373(9670):1175-82.
  • [42]Reichlin T, Potocki M, Breidthardt T, Noveanu M, Hartwiger S, Burri E, Reichlin T, Potocki M, Breidthardt T, Noveanu M, Hartwiger S, Burri E et al.. Diagnostic and prognostic value of uric acid in patients with acute dyspnea. Am J Med. 2009; 122(11):1054.
  • [43]Vandal K, Rouleau P, Boivin A, Ryckman C, Talbot M, Tessier PA. Blockade of S100A8 and S100A9 suppresses neutrophil migration in response to lipopolysaccharide. J Immunol. 2003; 171(5):2602-9.
  • [44]Ehlermann P, Eggers K, Bierhaus A, Most P, Weichenhan D, Greten J et al.. Increased proinflammatory endothelial response to S100A8/A9 after preactivation through advanced glycation end products. Cardiovasc Diabetol. 2006; 5:6. BioMed Central Full Text
  • [45]Boyd JH, Kan B, Roberts H, Wang Y, Walley KR. S100A8 and S100A9 mediate endotoxin-induced cardiomyocyte dysfunction via the receptor for advanced glycation end products. Circ Res. 2008; 102(10):1239-46.
  • [46]Vogl T, Tenbrock K, Ludwig S, Leukert N, Ehrhardt C, van Zoelen MA et al.. Mrp8 and Mrp14 are endogenous activators of Toll-like receptor 4, promoting lethal, endotoxin-induced shock. Nat Med. 2007; 13(9):1042-9.
  • [47]Potocki M, Breidthardt T, Reichlin T, Morgenthaler NG, Bergmann A, Noveanu M et al.. Midregional pro-adrenomedullin in addition to b-type natriuretic peptides in the risk stratification of patients with acute dyspnea: an observational study. Crit Care. 2009; 13(4):R122. BioMed Central Full Text
  • [48]Mebazaa A, Nieminen MS, Filippatos GS, Cleland JG, Salon JE, Thakkar R et al.. Levosimendan vs. dobutamine: outcomes for acute heart failure patients on beta-blockers in SURVIVE. Eur J Heart Fail. 2009; 11(3):304-11.
  • [49]Noveanu M, Breidthardt T, Reichlin T, Gayat E, Potocki M, Pargger H et al.. Effect of oral beta-blocker on short and long-term mortality in patients with acute respiratory failure: results from the BASEL-II-ICU study. Crit Care. 2010; 14(6):R198. BioMed Central Full Text
  • [50]Le Gall JR, Lemeshow S, Saulnier F. A new simplified acute physiology score (SAPS II) based on a European/North American multicenter study. JAMA. 1993; 270(24):2957-63.
  • [51]Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H et al.. The SOFA (sepsis-related organ failure assessment) score to describe organ dysfunction/failure. On behalf of the working group on sepsis-related problems of the European Society of intensive care medicine. Intensive Care Med. 1996; 22(7):707-10.
  • [52]McCabe WRJG. Gram negative bacteremia: I. Etiology and ecology. Arch Intern Med. 1962; 110:845-7.
  • [53]Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974; 2(7872):81-4.
  • [54]Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R et al.. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001; 29(7):1370-9.
  • [55]Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983; 67(6):361-70.
  • [56]Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992; 30(6):473-83.
  • [57]Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T et al.. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992; 305(6846):160-4.
  • [58]Brunet A, St-Hilaire A, Jehel L, King S. Validation of a French version of the impact of event scale-revised. Can J Psychiatry. 2003; 48(1):56-61.
  • [59]Van Buuren S, Groothuis-Oudshoorn K. mice: Multivariate Imputation by Chained Equations in R. J Stat Softw. 2011; 45(3):1-67.
  • [60]Hsieh FY, Bloch DA, Larsen MD. A simple method of sample size calculation for linear and logistic regression. Stat Med. 1998; 17(14):1623-34.
  • [61]Harrell FE, Lee KL, Mark DB. Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med. 1996; 15(4):361-87.
  • [62]le Cessie S, van Houwelingen HC. Testing the fit of a regression model via score tests in random effects models. Biometrics. 1995; 51(2):600-14.
  • [63]Hlatky MA, Greenland P, Arnett DK, Ballantyne CM, Criqui MH, Elkind MS et al.. Criteria for evaluation of novel markers of cardiovascular risk: a scientific statement from the American Heart Association. Circulation. 2009; 119(17):2408-16.
  • [64]Pencina MJ, D'Agostino RB, D'Agostino RB, Vasan RS. Evaluating the added predictive ability of a new marker: from area under the ROC curve to reclassification and beyond. Stat Med. 2008; 27(2):157-72.
  • [65]Cook NR. Use and misuse of the receiver operating characteristic curve in risk prediction. Circulation. 2007; 115(7):928-35.
  • [66]Perneger TV, Leplege A, Etter JF, Rougemont A. Validation of a French-language version of the MOS 36-Item Short Form Health Survey (SF-36) in young healthy adults. J Clin Epidemiol. 1995; 48(8):1051-60.
  • [67]Knaus WA, Zimmerman JE, Wagner DP, Draper EA, Lawrence DE. APACHE-acute physiology and chronic health evaluation: a physiologically based classification system. Crit Care Med. 1981; 9(8):591-7.
  • [68]Knaus WA, Wagner DP, Draper EA, Zimmerman JE, Bergner M, Bastos PG et al.. The APACHE III prognostic system. Risk prediction of hospital mortality for critically ill hospitalized adults. Chest. 1991; 100(6):1619-36.
  • [69]Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985; 13(10):818-29.
  • [70]Zimmerman JE, Kramer AA, McNair DS, Malila FM. Acute Physiology and Chronic Health Evaluation (APACHE) IV: hospital mortality assessment for today's critically ill patients. Crit Care Med. 2006; 34(5):1297-310.
  • [71]Moreno RP, Metnitz PG, Metnitz B, Bauer P, Afonso de Carvalho S, Hoechtl A. Modeling in-hospital patient survival during the first 28 days after intensive care unit admission: a prognostic model for clinical trials in general critically ill patients. J Crit Care. 2008; 23(3):339-48.
  • [72]Marshall JC, Cook DJ, Christou NV, Bernard GR, Sprung CL, Sibbald WJ. Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome. Crit Care Med. 1995; 23(10):1638-52.
  • [73]Fernandez R, Baigorri F, Navarro G, Artigas A. A modified McCabe score for stratification of patients after intensive care unit discharge: the Sabadell score. Crit Care. 2006; 10(6):R179. BioMed Central Full Text
  文献评价指标  
  下载次数:4次 浏览次数:12次