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Respiratory Distress Syndrome, AdultALTOSNCT00719446

Evaluating Health Outcomes and QOL After ALI Among Participants of the ALTA, OMEGA, EDEN, and SAILS ARDS Network Trials

An observational study of Respiratory Distress Syndrome, Adult, run by Johns Hopkins University at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Respiratory Distress Syndrome, Adult
How many people
922 participants
Where
6 sitesUnited States
Study dates
Oct 2007to Oct 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants who were enrolled in the ALTA, EDEN, OMEGA, or SAILS study.

Who may be able to join

  • Participated in the ALTA, EDEN, OMEGA, or SAILS study
  • Survived until hospital discharge

Who cannot join

  • Does not understand or speak English
  • Has no fixed address
  • Pre-existing cognitive impairment that prevents completion of the study assessments

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Johns Hopkins University

    Baltimore, Maryland, 21205

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • University of Washington/Harborview Medical Center

    Seattle, Washington, 98104

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Patient Outcomes 6 and 12 Months After ALTA, OMEGA, EDEN and SAILS ARDS Network Trials

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.

Read the detailed description

ALI, a life-threatening condition that involves inflammation of the lungs and fluid accumulation in the air sacs, typically leads to low blood oxygen levels and respiratory failure. Common causes of ALI include pneumonia, sepsis, and lung trauma. Symptoms, including breathing difficulty, low blood pressure, and organ failure, usually develop within 24 to 48 hours of the original injury or illness. Most patients require immediate care in an intensive care unit (ICU), and the main form of treatment is mechanical ventilation, which delivers oxygen and a continuous level of pressure to the damaged lungs. The ARDS Network (ARDSNet) is a group of hospitals and medical centers that conduct research to improve treatment options for people with ARDS and ALI. This study will enroll people who participated in the ARDSNet's ALTA, OMEGA, EDEN, or SAILS study; these studies are investigating new treatments to improve survival and reduce the amount of time people remain on mechanical ventilation in the ICU after ALI. It is not known whether the ARDSNet's treatments have any prolonged benefit for patients after they leave the hospital. The purpose of this study is to evaluate participants' quality of life and long-term health outcomes after they receive the ALTA, OMEGA, EDEN, or SAILS study treatments.

This study will enroll participants who were in the ALTA, OMEGA, EDEN, or SAILS study. ARDS Network trial participants from sites that approved this follow-up study will be contacted by phone at 6 and 12 months to complete a collection of surveys. These surveys assess quality of life, mental health, memory and cognition, physical functioning, fatigue, employment and health insurance status, and health care utilization. At the end of each follow-up, participants will be asked for feedback regarding their experience during the follow-up.

For participants from a sub-set of ARDS Network study sites participating in this study, researchers will review participants' medical records and information collected during the ARDSNet studies. Six and 12 months after ALI, participants will attend study visits at which time walking ability, lung function, and muscle strength will be measured. Weight, dietary changes, and changes in muscle and fat composition will also be assessed. Participants will take part in interviews to evaluate memory and cognition. If participants cannot attend the study visits, research staff will either visit participants' homes to complete the evaluations or conduct some of the evaluations over the phone.

Keywords
Acute Lung Injury
Medical subject headings
Respiratory Distress Syndrome, Acute Lung Injury

What is being measured

The primary outcome is the main question the study is designed to answer.

  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: Measured at Months 6 and 12

Secondary outcomes (1)

  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

    Short Form-36 domains, EQ-5D, Hospital Anxiety and Depression Scale, Impact of Event Scale-Revised, Mini-Mental State Examination, FACIT-Fatigue, Functional Performance Inventory, Wechsler Memory Scale - Logical Memory 1/2, Wechsler Adult Intelligence Scale - Digit Span and Similarities, Controlled Oral Word Association Test, Hayling Sentence Completion, Cognistat - Orientation and Judgment, Timed 4 Meter Walk, Hand grip, Manual Muscle Test, Maximal Inspiratory Pressure, Anthropometrics, DEXA

    Measured: Measured at Months 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
922 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00719446
Sponsor's protocol ID
589
Other IDs
R01HL091760
Acronym
ALTOS
Status last verified
Aug 2015
First submitted
18 Jul 2008
Last updated
1 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27440140

  • Dinglas 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.

    PubMed 26936876

  • Needham 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.

    PubMed 26832963

  • Dinglas 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.

    PubMed 25575599

  • Needham 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.

    PubMed 23512759

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Distress Syndrome, Adult, run by Johns Hopkins University at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Measured at Months 6 and 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00719446, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2015.

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