Literature DB >> 29420341

Is Overall Mortality the Right Composite Endpoint in Clinical Trials of Acute Respiratory Distress Syndrome?

Jesús Villar1,2, Domingo Martínez3, Fernando Mosteiro4, Alfonso Ambrós5, José M Añón1,6, Carlos Ferrando1,7, Juan A Soler3, Raquel Montiel8, Anxela Vidal9, Luís A Conesa-Cayuela3, Jesús Blanco1,10, Regina Arrojo4, Rosario Solano11, Lucía Capilla12, Rafael Del Campo5, Belén Civantos6, María Mar Fernández13, César Aldecoa14, Laura Parra15, Andrea Gutiérrez7, Chanel Martínez-Jiménez16, Jesús M González-Martín17, Rosa L Fernández1,2, Robert M Kacmarek18,19.   

Abstract

OBJECTIVES: Overall mortality in patients with acute respiratory distress syndrome is a composite endpoint because it includes death from multiple causes. In most acute respiratory distress syndrome trials, it is unknown whether reported deaths are due to acute respiratory distress syndrome or the underlying disease, unrelated to the specific intervention tested. We investigated the causes of death after contracting acute respiratory distress syndrome in a large cohort.
DESIGN: A secondary analysis from three prospective, multicenter, observational studies.
SETTING: A network of multidisciplinary ICUs. PATIENTS: We studied 778 patients with moderate-to-severe acute respiratory distress syndrome treated with lung-protective ventilation.
INTERVENTIONS: None.
MEASUREMENTS AND MAIN RESULTS: We examined death in the ICU from individual causes. Overall ICU mortality was 38.8% (95% CI, 35.4-42.3). Causes of acute respiratory distress syndrome modified the risk of death. Twenty-three percent of deaths occurred from refractory hypoxemia due to nonresolving acute respiratory distress syndrome. Most patients died from causes unrelated to acute respiratory distress syndrome: 48.7% of nonsurvivors died from multisystem organ failure, and cancer or brain injury was involved in 37.1% of deaths. When quantifying the true burden of acute respiratory distress syndrome outcome, we identified 506 patients (65.0%) with one or more exclusion criteria for enrollment into current interventional trials. Overall ICU mortality of the "trial cohort" (21.3%) was markedly lower than the parent cohort (relative risk, 0.55; 95% CI, 0.43-0.70; p < 0.000001).
CONCLUSIONS: Most deaths in acute respiratory distress syndrome patients are not directly related to lung damage but to extrapulmonary multisystem organ failure. It would be challenging to prove that specific lung-directed therapies have an effect on overall survival.

Entities:  

Mesh:

Year:  2018        PMID: 29420341     DOI: 10.1097/CCM.0000000000003022

Source DB:  PubMed          Journal:  Crit Care Med        ISSN: 0090-3493            Impact factor:   7.598


  10 in total

Review 1.  Lung Repair and Regeneration in ARDS: Role of PECAM1 and Wnt Signaling.

Authors:  Jesús Villar; Haibo Zhang; Arthur S Slutsky
Journal:  Chest       Date:  2018-10-28       Impact factor: 9.410

2.  Epidemiology of Cause of Death in Pediatric Acute Respiratory Distress Syndrome.

Authors:  Jasmine C Dowell; Kaushik Parvathaneni; Neal J Thomas; Robinder G Khemani; Nadir Yehya
Journal:  Crit Care Med       Date:  2018-11       Impact factor: 7.598

3.  PEEP titration guided by transpulmonary pressure: lessons from a negative trial.

Authors:  Fernando Suarez-Sipmann; Carlos Ferrando; Jesús Villar
Journal:  J Thorac Dis       Date:  2019-09       Impact factor: 2.895

4.  Acute Respiratory Distress Syndrome Following Pediatric Trauma: Application of Pediatric Acute Lung Injury Consensus Conference Criteria.

Authors:  Elizabeth Y Killien; Roel L N Huijsmans; Iesha L Ticknor; Lincoln S Smith; Monica S Vavilala; Frederick P Rivara; R Scott Watson
Journal:  Crit Care Med       Date:  2020-01       Impact factor: 7.598

Review 5.  Definition and global epidemiology of pediatric acute respiratory distress syndrome.

Authors:  Fernando Beltramo; Robinder G Khemani
Journal:  Ann Transl Med       Date:  2019-10

6.  Rapidly Improving ARDS in Therapeutic Randomized Controlled Trials.

Authors:  Edward J Schenck; Clara Oromendia; Lisa K Torres; David A Berlin; Augustine M K Choi; Ilias I Siempos
Journal:  Chest       Date:  2018-10-22       Impact factor: 9.410

7.  Predicting Mortality in Children With Pediatric Acute Respiratory Distress Syndrome: A Pediatric Acute Respiratory Distress Syndrome Incidence and Epidemiology Study.

Authors:  Nadir Yehya; Michael O Harhay; Margaret J Klein; Steven L Shein; Byron E Piñeres-Olave; Ledys Izquierdo; Anil Sapru; Guillaume Emeriaud; Philip C Spinella; Heidi R Flori; Mary K Dahmer; Aline B Maddux; Yolanda M Lopez-Fernandez; Bereketeab Haileselassie; Deyin Doreen Hsing; Ranjit S Chima; Amanda B Hassinger; Stacey L Valentine; Courtney M Rowan; Martin C J Kneyber; Lincoln S Smith; Robinder G Khemani; Neal J Thomas
Journal:  Crit Care Med       Date:  2020-06       Impact factor: 7.598

Review 8.  Respiratory Subsets in Patients with Moderate to Severe Acute Respiratory Distress Syndrome for Early Prediction of Death.

Authors:  Jesús Villar; Cristina Fernández; Jesús M González-Martín; Carlos Ferrando; José M Añón; Ana M Del Saz-Ortíz; Ana Díaz-Lamas; Ana Bueno-González; Lorena Fernández; Ana M Domínguez-Berrot; Eduardo Peinado; David Andaluz-Ojeda; Elena González-Higueras; Anxela Vidal; M Mar Fernández; Juan M Mora-Ordoñez; Isabel Murcia; Concepción Tarancón; Eleuterio Merayo; Alba Pérez; Miguel A Romera; Francisco Alba; David Pestaña; Pedro Rodríguez-Suárez; Rosa L Fernández; Ewout W Steyerberg; Lorenzo Berra; Arthur S Slutsky
Journal:  J Clin Med       Date:  2022-09-27       Impact factor: 4.964

9.  Acute respiratory distress syndrome-attributable mortality in critically ill patients with sepsis.

Authors:  Catherine L Auriemma; Hanjing Zhuo; Kevin Delucchi; Thomas Deiss; Tom Liu; Alejandra Jauregui; Serena Ke; Kathryn Vessel; Matthew Lippi; Eric Seeley; Kirsten N Kangelaris; Antonio Gomez; Carolyn Hendrickson; Kathleen D Liu; Michael A Matthay; Lorraine B Ware; Carolyn S Calfee
Journal:  Intensive Care Med       Date:  2020-03-23       Impact factor: 17.440

10.  Neurally adjusted ventilatory assist in acute respiratory failure: a randomized controlled trial.

Authors:  Robert M Kacmarek; Jesús Villar; Dácil Parrilla; Francisco Alba; Rosario Solano; Songqiao Liu; Raquel Montiel; Jesús Rico-Feijoo; Anxela Vidal; Carlos Ferrando; Isabel Murcia; Ruth Corpas; Elena González-Higueras; Qin Sun; César E Pinedo; David Pestaña; Domingo Martínez; César Aldecoa; José M Añón; Marina Soro; Jesús M González-Martín; Cristina Fernández; Rosa L Fernández
Journal:  Intensive Care Med       Date:  2020-09-06       Impact factor: 17.440

  10 in total

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