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

ALTA、OMEGA 和 EDEN ARDS 网络试验后 6 个月和 12 个月的患者结果

• 批准号: 7804573
• 负责人: RAMONA O HOPKINS
• 金额: $ 38.35万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-05-01 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7804573
• 关键词: Acute; Acute Lung Injury; Address; Adrenergic Agonists; Adult Respiratory Distress Syndrome; Affect; Albuterol; Albuterol Sulfate; American; Ancillary Study; Anti-Inflammatory Agents; Anti-inflammatory; Antioxidants; Attention; Breathing; Cessation of life; Clinical; Clinical Trials; Clinical Trials Network; Clinical assessments; Cognitive; Critical Care; Double-Blind Method; Enrollment; Enteral Feeding; Evaluation; Goals; HIV Infections; Health Status; Impairment; Incidence; Intensive Care Units; Intervention; Knowledge; Life; Long-Term Effects; Long-Term Survivors; Longitudinal Studies; Lung; Mechanical Ventilators; Mechanical ventilation; Mediating; Memory; Mental Depression; Mental Health; Morbidity - disease rate; Muscle Weakness; National Heart, Lung, and Blood Institute; Omega-3 Fatty Acids; Outcome; Outcome Assessment; Parents; Participant; Patient Outcomes Assessments; Patients; Persons; Physical Function; Placebo Control; Placebos; Psyche structure; Public Health; Quality of life; Reporting; Research; Respiratory Failure; Risk Factors; Sample Size; Sepsis; Site; Surveys; Survivors; Symptoms; Syndrome; Telephone; Testing; United States National Institutes of Health; abstracting; aerosolized; antioxidant therapy; base; cognitive function; cohort; design; dietary supplements; efficacy testing; executive function; field study; follow-up; functional status; gamma-Linolenic Acid; improved; insight; instrument; killings; malignant breast neoplasm; mortality; muscle strength; novel; pulmonary function; randomized trial; research clinical testing; Acute; Acute Lung Injury; Address; Adrenergic Agonists; Adult Respiratory Distress Syndrome; Affect; Albuterol; Albuterol Sulfate; American; Ancillary Study; Anti-Inflammatory Agents; Anti-inflammatory; Antioxidants; Attention; Breathing; Cessation of life; Clinical; Clinical Trials; Clinical Trials Network; Clinical assessments; Cognitive; Critical Care; Double-Blind Method; Enrollment; Enteral Feeding; Evaluation; Goals; HIV Infections; Health Status; Impairment; Incidence; Intensive Care Units; Intervention; Knowledge; Life; Long-Term Effects; Long-Term Survivors; Longitudinal Studies; Lung; Mechanical Ventilators; Mechanical ventilation; Mediating; Memory; Mental Depression; Mental Health; Morbidity - disease rate; Muscle Weakness; National Heart, Lung, and Blood Institute; Omega-3 Fatty Acids; Outcome; Outcome Assessment; Parents; Participant; Patient Outcomes Assessments; Patients; Persons; Physical Function; Placebo Control; Placebos; Psyche structure; Public Health; Quality of life; Reporting; Research; Respiratory Failure; Risk Factors; Sample Size; Sepsis; Site; Surveys; Survivors; Symptoms; Syndrome; Telephone; Testing; United States National Institutes of Health; abstracting; aerosolized; antioxidant therapy; base; cognitive function; cohort; design; dietary supplements; efficacy testing; executive function; field study; follow-up; functional status; gamma-Linolenic Acid; improved; insight; instrument; killings; malignant breast neoplasm; mortality; muscle strength; novel; pulmonary function; randomized trial; research clinical testing

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)

描述（由申请人提供）： 我们的总体目标是更好地了解幸存的急性肺损伤/急性呼吸窘迫综合征（“ ALI”）的患者的长期结局，并确定在三个新的NHLBI ARDS网络（ARDSNET）临床试验中测试的治疗是否会影响这些长期成果。 ALI是一种引起呼吸衰竭的综合征，需要在重症监护病房（ICU）中进行机械通气。该综合征是由多种肺（例如抽吸）和非肺（例如败血症）风险因素的多样化组引起的。阿里施加了巨大的公共卫生负担，其发病率高于先前所认识到的，总数类似于乳腺癌或艾滋病毒感染。随着ALI的短期死亡率提高了，更多的关注集中在越来越多的ALI幸存者面临的重大长期病毒上。目前，关于阿里幸存者的长期结果的知识不足，并且对ICU疗法对这些结果的影响鲜为人知。这项拟议的辅助研究将评估3项新的Ardsnet试验的6个月和12个月的结果。这些试验正在测试3种干预措施的功效（雾化的Albuterol与安慰剂，抗炎/抗氧化剂的营养补充剂与安慰剂的疗效，以及延迟与早期全热量肠内喂养的延迟对患者的短期生存和从机械气毒中解放。我们将评估阿里幸存者的整体生活质量及其主要的长期身体，认知和心理健康病态。具体而言，我们将确定在这些试验中测试的3种ICU疗法对（1）通过电话基于电话的长期结果对所有12个ARDSNET研究地点的幸存者的调查（AIMS 1A，2A和3A）的长期验证的影响； （2）临床结果，可以通过对参与这项辅助研究的4个Ardsnet站点的子集进行亲自评估来介导患者报告的结果（AIMS 1B，2B和3B）。所有这些结果评估否则将不在父母的试验中进行，而是代表评估ALI幸存者健康状况以及正在研究的3种疗法的长期影响的宝贵知识。按照Ardsnet的长期成果委员会的建议，使用经过验证的工具来评估身体能力，认知功能和心理健康的验证工具，将在本提案中的4个研究站点中的2个集中进行集中。对本提案的四个研究地点将对身体和认知功能进行详细的面对面评估。这种面对面的身体功能评估将使用标准的身体机能，肺功能，肌肉力量和人类图表的标准临床测试进行。认知功能的面对面评估将包括使用经过验证的工具来评估取向，注意力，记忆，推理和执行功能。 急性肺损伤/急性呼吸窘迫综合征（“ ALI”）导致威胁生命的呼吸问题，需要在重症监护病房（ICU）中使用机械呼吸机（人工呼吸器）。该综合征比以前被认可的更频繁地发生，并且杀死了比乳腺癌或艾滋病毒感染更多的美国人。但是，阿里的死亡率提高导致越来越多的人幸存这种综合症。我们的研究旨在更好地了解阿里幸存者的生活质量及其在阿里后6个月和12个月的主要身体，认知和心理健康成果，并确定在三项新的国家卫生研究院临床试验中测试的治疗是否可以改善这些结果。 （抽象的结尾）