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FRAIL PARTICIPANTS IN RANDOMIZED CONTROLLED TRIALS OF ACUTE RESPIRATORY DISTRESS SYNDROME.
Pubmed ID: 39993922
Journal: Shock (Augusta, Ga.)
Publication Date: March 1, 2025
MeSH Terms: Humans, Male, Female, Aged, Aged, 80 and over, Middle Aged, Randomized Controlled Trials as Topic, Intensive Care Units, Respiratory Distress Syndrome, Frailty
Authors: Siempos II, Giannakoulis VG, Kotanidou A, Papoutsi E, Routsi C, Papathanakos G, Vavouraki EA, Dimopoulou I, Ntaidou TK, Theodorou E
Cite As: Ntaidou TK, Giannakoulis VG, Papoutsi E, Vavouraki EA, Theodorou E, Papathanakos G, Dimopoulou I, Routsi C, Kotanidou A, Siempos II. FRAIL PARTICIPANTS IN RANDOMIZED CONTROLLED TRIALS OF ACUTE RESPIRATORY DISTRESS SYNDROME. Shock 2025 Mar 1;63(3):435-440. Epub 2025 Feb 7.
Studies:
- Acute Respiratory Distress Network (ARDSNet) Studies 06 and 08 Prospective, Randomized, Multicenter Trial of Aerosolized Albuterol Versus Placebo for the Treatment of Acute Lung Injury (ALTA)
- Acute Respiratory Distress Network (ARDSNet) Studies 07, 08, 09, 11, and 12 Early Versus Delayed Enteral Feeding to Treat People with Acute Lung Injury or Acute Respiratory Distress Syndrome (EDEN)
- Acute Respiratory Distress Network (ARDSNet) Studies 10 and 12 Statins for Acutely Injured Lungs from Sepsis (SAILS)
- Acute Respiratory Distress Network (ARDSNet) Study 05 Fluid and Catheter Treatment Trial (FACTT)
- Prevention and Early Treatment of Acute Lung Injury (PETAL) Network – Reevaluation of Systemic Early Neuromuscular Blockade (ROSE)
Abstract
Purpose: Observational studies showed that frailty is common in the intensive care unit and associated with poor outcomes. However, relevant data from interventional trials are scarce, and it is unknown whether outcomes improved over time. We endeavored to estimate temporal trends of representation and outcomes of frail participants in randomized controlled trials of acute respiratory distress syndrome (ARDS). Methods: We performed a secondary analysis of five ARDS Network and PETAL Network trials published between 2006 and 2019. Based on requirement for everyday assistance prior to hospitalization, we categorized participants into frail versus nonfrail. Results : Out of 3,630 participants with ARDS, 701 (19.3%) were frail. Representation of frail participants increased over time ( P = 0.001), while mortality remained stable ( P = 0.403) and as high as 39.4%. A total of 60.6% of frail participants were younger than 65 years old. Frailty was independently associated with 90-day mortality (odds ratio 1.62, 95% confidence interval 1.34-1.96, P < 0.001). Frail had fewer ventilator-free days and were more likely to have subsequent disability than nonfrail participants. Conclusion: In trials of ARDS, representation of frail participants increased, while their mortality did not improve over time. The ever-increasing vulnerable group of frail participants should be taken into consideration in the design of trials.