U-M Leading the Battle Against ARDS
More than 200,000 people develop Acute Respiratory Distress Syndrome (ARDS) each year in the U.S., and approximately 40 percent lose their lives to the disease, even with intensive treatment. The risk of death increases with age and severity of illness. This dangerous and aggressive lung condition results in severe hypoxemia (PaO2/FiO2 ratio < 300) and is associated with a variety of illnesses, including pneumonia, shock, sepsis and trauma.
The University of Michigan is one of the top institutions in the nation in ARDS treatment and research, bringing together medical and surgical clinicians and investigators to collaborate on new methods to better predict, diagnose and treat ARDS.
Clinical Research in ARDS
“One indication of Michigan’s leadership in ARDS is our involvement in the Clinical Trials Network for the Prevention and Early Treatment of Acute Lung Injury, or PETAL,” says Theodore Standiford, M.D., Chief of the U-M Division of Pulmonary and Critical Care Medicine. In 2014 U-M was selected as one of 12 Clinical Centers which, along with one Clinical Coordinating Center, comprise the PETAL network.
“The network is at the forefront of testing new treatments and approaches with the potential to improve outcomes for patients with ARDS and for those at risk of developing ARDS,” continues Standiford. “Our involvement with PETAL provides a unique platform to lead us to more and better options for our ARDS patients and our colleagues in critical care medicine.”
Funded by the National Heart, Lung, and Blood Institute (NHLBI) to develop and conduct randomized controlled ARDS prevention and treatment trials, the PETAL network builds on the strengths and accomplishments of the NHLBI-funded Acute Respiratory Distress Syndrome Clinical Trial Network and emergency/acute care medicine research groups to focus on prevention and earlier intervention.
At U-M, PETAL is led by Project Director Robert Hyzy, M.D. of the Division of Pulmonary and Critical Care Medicine. Hyzy and Pauline Park, M.D. of the Division of Acute Care Surgery are co-principal investigators and work closely with Kyle Gunnerson, M.D., Director of the Emergency Critical Care Center at University of Michigan Hospital. “PETAL’s focus on teamwork lets us forge new partnerships and devise new methods for early diagnosis and treatment of ARDS,” says Hyzy. “Clinicians from many areas work together on projects,” he continues. “For example, the U-M PETAL site is collaborating with Henry Ford Hospital in Detroit to enroll patients in PETAL network studies.”
Through the PETAL network, U-M investigators are initiating a number of novel clinical trials, including the following:
- Testing the early introduction of neuromuscular blocking agents in the treatment of patients with severe ARDS (Re-evaluation Of Systemic Early neuromuscular blockade, or ‘ROSE’ trial). This study is scheduled to begin recruiting patients in the next six months.
- Assessing the effectiveness of Vitamin D replacement on prevention of ARDS and clinical outcomes in critically ill patients at risk for ARDS. This study is scheduled to begin recruiting patients in the next six months.
Studies like these also afford the opportunity to perform molecular phenotyping of patients to correlate with treatment responses, with the ultimate goal of providing a more personalized approach to ARDS therapy in a particular patient. These studies also allow investigators to assess the influence of specific therapies on the lung microbiome during ARDS.
Another distinct advantage of U-M’s involvement in PETAL is the ability to study the long term outcomes of patients who survive ARDS:
- U-M investigator Theodore Iwashyna, Ph.D., M.D. is leading an initiative to define the experience of survivorship after ARDS, particularly with severe sepsis. Evidence increasingly suggests that severe sepsis is not only life-threatening, but also life-altering, resulting in significant adverse consequences for those who survive. In collaboration with the Health and Retirement Study and others, Iwashyna’s team is working to measure long-term functional, cognitive and health care outcomes after severe sepsis. The goal is to establish the mechanisms by which these long-term changes occur with an eye to interventions, particularly hospital-based approaches, to improve the lives of survivors.
Researchers within the U-M Department of Surgery are also making significant contributions to our understanding of ARDS, and to continuing to optimize preventive strategies and to develop new and better treatment options for patients. Examples include:
- Lena Napolitano, M.D. and Pauline Park, M.D. are among several U-M clinical investigators conducting studies to understand why some people develop Acute Respiratory Distress Syndrome (ARDS) while others don't. "It could be a genetic predisposition that leads some people to develop ARDS," says Napolitano, Division Chief of Acute Care Surgery and Chief of Surgical Critical Care for the Department of Surgery. "In fact, a patient's response to the initial acute lung injury may be a more critical determinant of the outcome of ARDS than the original inciting stimulus that caused ARDS. We are investigating a number of mechanisms and a group of investigators here is now studying the disease in a comprehensive way."
- U-M research is currently underway to improve extracorporeal membrane oxygenation (ECMO) therapy. A highly-invasive and potentially risky therapy, ECMO is a treatment strategy for patients with severe ARDS that was developed by U-M critical-care pioneer Robert Bartlett, M.D. During the therapy, a patient's blood is processed through an ECMO circuit, which replaces the normal gas-exchange function of the lungs, removing carbon dioxide and adding oxygen. Oxygenated blood is then returned to the patient. Bartlett’s team, including doctors Gunnerson, Park and Napolitano, are working to identify ways to make ECMO easier to administer and less risky for patients.
- Spearheaded by Napolitano, U-M is also developing the nation's first ARDS registry with long-term follow-up. In the field of transplant medicine and cardiac care, national patient registries provide a valuable way to compile and analyze data on patients, their care, and the outcomes of their care. No such registry yet exists in the field of acute care surgery in ARDS. Collecting clinical data to analyze long-term patient outcomes will be a valuable tool in the epidemiology of ARDS, providing important information on the relative value of various treatment strategies.
Reducing ARDS mortality through early treatment and education
U-M clinicians are also at the forefront of efforts to reduce ARDS mortality rates through early diagnosis and treatment. “What experts do know is that ARDS develops rapidly, so it's critical that the disease be diagnosed and treated immediately, says Napolitano. “An ARDS patient should be transferred to a regional ARDS referral center like U-M when his or her blood oxygen level, or P/F (PaO2/FiO2) ratio, drops to 100, which signals severe ARDS.”
“At that level, patients are stable enough to transfer and we have time to try multiple lifesaving therapies,” continues Napolitano. “We send our Survival Flight team to transport these patients since they have special expertise in the transport and management of severe ARDS patients. When we get patients transferred in for severe ARDS early, we have great success in treatment.”
U-M has developed evidence-based treatment protocols for the treatment of ARDS and severe acute respiratory failure, and is the only medical facility in the region equipped to perform many life-saving procedures and advanced interventions, including ECMO. U-M is one of only a handful of institutions in the country where ECMO is available for ARDS treatment in adults.
Find more information on when to consult with or transfer a patient to our ECMO Center here.
Unfortunately, patient transfers often occur too late when their blood oxygen level is so low that it makes transport risky. In response, the U-M Critical Care team is undertaking a focused effort to raise awareness about ARDS, its rapid progression, and effective treatment strategies among healthcare providers regionally and nationally. U-M experts are available to offer training and support (both online and at regional symposia) for medical professionals on highly-effective ARDS treatments as well as to provide diagnostic tools to ensure ARDS cases are diagnosed early, blood oxygen levels are monitored closely, and patients are transferred when necessary.
The U-M Division of Pulmonary and Critical Care Medicine offers the entire continuum of care to patients with ARDS. This includes state-of-the-art management with lung protective ventilation, neuromuscular blockade and prone ventilation. After patients are managed by the Critical Care Medicine Unit teams, when clinically indicated, patients can be referred to the Division of Acute Care Surgery for extracorporeal support (ECMO). The Critical Care Medicine Unit should be the first stop for management of patients with all forms of lung failure when admitted via our emergency room or transferred from another facility.
To speak with a U-M critical care physician, learn more about clinical research in ARDS, or refer a patient 24 hours a day, call M-Line at 800-962-3555. When you call, request transfer to the “CCMU service” or the medical ICU so that your patient can gain access to our state-of-the art care.