Patient Outcomes 6 and 12 Months After ALTA, OMEGA and EDEN ARDS Network Trials

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DESCRIPTION (provided by applicant): Our overall objective is to better understand the long-term outcomes of patients surviving acute lung injury/acute respiratory distress syndrome ("ALI") and determine if therapies being tested in three new NHLBI ARDS Network (ARDSNet) clinical trials affect these long-term outcomes. ALI is a syndrome causing respiratory failure and requiring mechanical ventilation in an intensive care unit (ICU). This syndrome is caused by a diverse group of both pulmonary (e.g., aspiration) and non-pulmonary (e.g., sepsis) risk factors. ALI imposes a significant public health burden with a higher incidence than previously recognized and a total number of deaths similar to breast cancer or HIV infection. As the short-term mortality rate for ALI has improved, greater attention has focused on the significant longer-term morbidities faced by the growing number of ALI survivors. At present, there is inadequate knowledge regarding long-term outcomes of ALI survivors and little known about the effect of ICU therapies on these outcomes. This proposed ancillary study will evaluate the 6- and 12-month outcomes of 3 new ARDSNet trials. These trials are testing the efficacy of 3 interventions (nebulized albuterol vs. placebo, anti-inflammatory/anti-oxidant nutritional supplement vs. placebo, and delayed vs. early full-calorie enteral feeding) on patients' short-term survival and liberation from mechanical ventilation. We will evaluate ALI survivors' overall quality of life, and their major long-term physical, cognitive and mental health morbidities. Specifically, we will determine the effect of the 3 ICU therapies being tested in these trials on (1) patient-reported long-term outcomes via phone- based surveys of survivors from all 12 ARDSNet study sites (Aims 1a, 2a and 3a); and (2) clinical outcomes, which may mediate the patient-reported outcomes, via in-person evaluations of survivors from a subset of 4 ARDSNet sites participating in this ancillary study (Aims 1b, 2b and 3b). All of these outcome assessments will not otherwise be conducted in the parent trials, but represent invaluable knowledge in evaluating the health status of ALI survivors and the long-term effect of the 3 therapies under study. All phone surveys for participants will be centralized at 2 of the 4 study sites in this proposal, using validated instruments for assessing physical capabilities, cognitive function and mental health, as recommended by the ARDSNet Long-Term Outcomes Committee. Detailed, in-person evaluations of physical and cognitive function will be performed at the 4 study sites participating in this proposal. This in-person evaluation of physical function will be conducted using standard clinical tests of overall physical function, pulmonary function, muscle strength and anthropometrics. In-person evaluation of cognitive function will include use of validated instruments for assessing orientation, attention, memory, reasoning and executive function. Acute lung injury/acute respiratory distress syndrome ("ALI") causes life-threatening breathing problems requiring the use of a mechanical ventilator (artificial respirator) in an intensive care unit (ICU). This syndrome occurs more frequently than previously recognized and kills more Americans than breast cancer or HIV infection; however, an improvement in the mortality rate from ALI has led to a growing number of people surviving this syndrome. Our study aims to better understand ALI survivors' quality of life and their major physical, cognitive and mental health outcomes at 6- and 12-months after ALI and to determine if treatments being tested in three new National Institutes of Health clinical trials can improve these outcomes. (End of Abstract)