Evaluating Health Outcomes and QOL After ALI Among Participants of the ALTA, OMEGA, EDEN, and SAILS ARDS Network Trials
ALTOS
Patient Outcomes 6 and 12 Months After ALTA, OMEGA, EDEN and SAILS ARDS Network Trials
2 other identifiers
observational
922
1 country
6
Brief Summary
Acute lung injury (ALI) is a severe lung condition that causes respiratory failure. The ARDS Network (ARDSNet) is a National Heart, Lung, and Blood Institute-sponsored network that is focused on improving treatments for people with ALI and a similar condition called acute respiratory distress syndrome (ARDS). This study will evaluate participants who were enrolled in one of three ARDSNet studies to examine how the treatments carried out in the prior studies affect participants' long-term health outcomes and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2007
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 18, 2008
CompletedFirst Posted
Study publicly available on registry
July 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedSeptember 1, 2015
August 1, 2015
7 years
July 18, 2008
August 31, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Individual Physical Function and Mental Health domains from SF-36 (for participants who complete the phone surveys); 6-minute walk distance and memory evaluation (for participants who attend the study visits)
Measured at Months 6 and 12
Secondary Outcomes (1)
Quality of life, mental health, memory and cognition, physical functioning, fatigue, walking ability, lung function, muscle strength, weight, dietary changes, and changes in muscle and fat composition
Measured at Months 6 and 12
Other Outcomes (1)
Health Care Utilization, Employment Status, Health Insurance Status
Measured at Months 6 and 12
Eligibility Criteria
Participants who were enrolled in the ALTA, EDEN, OMEGA, or SAILS study.
You may qualify if:
- Participated in the ALTA, EDEN, OMEGA, or SAILS study
- Survived until hospital discharge
You may not qualify if:
- Does not understand or speak English
- Has no fixed address
- Pre-existing cognitive impairment that prevents completion of the study assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Washington/Harborview Medical Center
Seattle, Washington, 98104, United States
Related Publications (5)
Brown SM, Wilson E, Presson AP, Zhang C, Dinglas VD, Greene T, Hopkins RO, Needham DM; with the National Institutes of Health NHLBI ARDS Network. Predictors of 6-month health utility outcomes in survivors of acute respiratory distress syndrome. Thorax. 2017 Apr;72(4):311-317. doi: 10.1136/thoraxjnl-2016-208560. Epub 2016 Jul 20.
PMID: 27440140DERIVEDDinglas VD, Hopkins RO, Wozniak AW, Hough CL, Morris PE, Jackson JC, Mendez-Tellez PA, Bienvenu OJ, Ely EW, Colantuoni E, Needham DM. One-year outcomes of rosuvastatin versus placebo in sepsis-associated acute respiratory distress syndrome: prospective follow-up of SAILS randomised trial. Thorax. 2016 May;71(5):401-10. doi: 10.1136/thoraxjnl-2015-208017. Epub 2016 Mar 2.
PMID: 26936876DERIVEDNeedham DM, Colantuoni E, Dinglas VD, Hough CL, Wozniak AW, Jackson JC, Morris PE, Mendez-Tellez PA, Ely EW, Hopkins RO. Rosuvastatin versus placebo for delirium in intensive care and subsequent cognitive impairment in patients with sepsis-associated acute respiratory distress syndrome: an ancillary study to a randomised controlled trial. Lancet Respir Med. 2016 Mar;4(3):203-12. doi: 10.1016/S2213-2600(16)00005-9. Epub 2016 Jan 29.
PMID: 26832963DERIVEDDinglas VD, Huang M, Sepulveda KA, Pinedo M, Hopkins RO, Colantuoni E, Needham DM; NIH NHLBI ARDS Network. Personalized contact strategies and predictors of time to survey completion: analysis of two sequential randomized trials. BMC Med Res Methodol. 2015 Jan 9;15:5. doi: 10.1186/1471-2288-15-5.
PMID: 25575599DERIVEDNeedham DM, Dinglas VD, Bienvenu OJ, Colantuoni E, Wozniak AW, Rice TW, Hopkins RO; NIH NHLBI ARDS Network. One year outcomes in patients with acute lung injury randomised to initial trophic or full enteral feeding: prospective follow-up of EDEN randomised trial. BMJ. 2013 Mar 19;346:f1532. doi: 10.1136/bmj.f1532.
PMID: 23512759DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dale M. Needham, MD, PhD
Johns Hopkins University
- PRINCIPAL INVESTIGATOR
Ramona O Hopkins, PhD
Intermountain Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 18, 2008
First Posted
July 21, 2008
Study Start
October 1, 2007
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
September 1, 2015
Record last verified: 2015-08