Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00719446
Other study ID # 589
Secondary ID R01HL091760
Status Completed
Phase N/A
First received July 18, 2008
Last updated August 31, 2015
Start date October 2007
Est. completion date October 2014

Study information

Verified date August 2015
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 922
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Participated in the ALTA, EDEN, OMEGA, or SAILS study

- Survived until hospital discharge

Exclusion Criteria:

- Does not understand or speak English

- Has no fixed address

- Pre-existing cognitive impairment that prevents completion of the study assessments

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Acute Lung Injury
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn

Locations

Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States University of Maryland Medical Center Baltimore Maryland
United States Intermountain Medical Center Murray Utah
United States Vanderbilt University Nashville Tennessee
United States University of Washington/Harborview Medical Center Seattle Washington
United States Wake Forest University Winston Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Health Care Utilization, Employment Status, Health Insurance Status Measured at Months 6 and 12 No
Primary 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 No
Secondary 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 at Months 6 and 12 No
See also
  Status Clinical Trial Phase
Completed NCT03712215 - STUDY OF ELECTRICAL STIMULATION IN PULMONARY FUNCTION IN INTENSIVE CARE UNIT N/A
Completed NCT04582201 - Evaluate the Safety of agenT-797 in Participants With Moderate to Severe Difficulty Breathing Secondary to SARS-CoV-2 Phase 1/Phase 2
Recruiting NCT01990456 - Strategies for Optimal Lung Ventilation in ECMO for ARDS: The SOLVE ARDS Study N/A
Completed NCT01167621 - Changes in Refractory Acute Respiratory Distress Syndrome (ARDS) Patients Under High Frequency Oscillation-ventilation N/A
Terminated NCT00233207 - IC14 Antibodies to Treat Individuals With Acute Lung Injury Phase 2
Completed NCT00029328 - Etanercept for Non-Infectious Lung Injury Following Bone Marrow Transplantation Phase 1/Phase 2
Completed NCT00004494 - Phase I Study of Vasoactive Intestinal Peptide in Patients With Acute Respiratory Distress Syndrome and Sepsis Phase 1
Completed NCT00000579 - Acute Respiratory Distress Syndrome Clinical Network (ARDSNet) Phase 3
Recruiting NCT03236272 - Establishment of a Biomarkers-based Early Warning System of Acute Respiratory Distress Syndrome (ARDS)
Withdrawn NCT04508933 - Comparison of Extra Vascular Lung Water Index in Covid-19 ARDS and "Typical"ARDS Patients
Completed NCT02273687 - Time-motion-mode Ultrasound Diaphragm Measures in Patients With Acute Respiratory Distress in Emergency Department N/A
Recruiting NCT03424798 - Measuring Heart and Lung Function in Critical Care N/A
Recruiting NCT01992237 - Measuring Energy Expenditure in ECMO (Extracorporeal Membrane Oxygenation) Patients N/A
Completed NCT00236262 - Effect of Positive Expiratory Pressure on Right Ventricular Function in Patients With Respiratory Distress Syndrome N/A
Completed NCT00157144 - Australia and New Zealand Adult Extracorporeal Membrane Oxygenation (ECMO) Audit 2005 N/A
Completed NCT00300248 - Long-Term Results in Mechanically Ventilated Individuals With Acute Lung Injury/Acute Respiratory Distress Syndrome N/A
Completed NCT00141726 - Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant Phase 2
Recruiting NCT00465374 - A Validation/Interventional Study on Stress Index in Predicting Mechanical Stress in ARDS Patients Phase 3
Completed NCT00094406 - Carbon Monoxide to Prevent Lung Inflammation Phase 1
Recruiting NCT03709199 - Long Term Follow up of Children Enrolled in the REDvent Study