Adult Surviving Sepis Campaign Guidelines (Hour-1 Bundle)
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Discovery provides many opportunities for clinical investigators, including submission and presentation of new clinical proposals. Once reviewed and presented, these proposals can become Endorsed Projects or Discovery Programs.
The Discovery Clinical Investigators Meetings offer researchers unique opportunities to submit their ideas to Discovery and receive valuable peer feedback. Proposals are reviewed and evaluated by members of the Discovery Steering Committee. In addition to Overall Impact Score, investigators are provided with a score and comments in the following areas: Significance, Investigator, Innovation, Approach, and Environment. Investigators will have the opportunity to present their proposals at a Discovery Clinical Investigators Meeting. These presentations can be made virtually or in person. Time is allowed for questions and additional feedback.
Submit a Proposal
Preview the submission form. (Note: All proposals must be submitted via the link above. You cannot print and email this PDF.) If you have questions, please contact email@example.com.
Vitamin C, Corticosteroids and Thiamine in Sepsis Study VICTAS
Jonathan Sevransky, MD, MHS
Sepsis is a clinical syndrome characterized by life-threatening organ dysfunction, caused by a dysregulated host response to infection.1. The treatment of sepsis currently consists of expedient supportive care and control of infection.2. Recently, a combination of inexpensive medications has been asserted to effectively combat the dysregulated metabolism that accompanies sepsis. These medications include Vitamin C, Thiamine (also known as Vitamin B1), and hydrocortisone.. The assertion is based on the before-after data reported by a single hospital. The response to this trial, which received widespread interest of the public ,has been mixed, with some clinicians suggesting that the results are “too good to be true” to “why not give the combination of medications to all sepsis patients?” The most general opinion reflects clinical equipoise: genuine uncertainty in the expert medical community over whether the medication combination treatment will be beneficial, with reciprocal uncertainty as to whether the medication combination will be wasteful or even harmful.
Early after TBI Study: Opposing Sympathetic Drive Early after Traumatic Brain Injury-Phase 3 OSD-3
Bellal Joseph, MD, FACS
Severe TBI is defined by a Glasgow Coma Scale (GCS) ≤ 8. This sets a host-adaptive neuroendocrine, immune-metabolic, and inflammatory response that is integrated by an increased sympathetic drive and exaggerated catecholamine surge. This unopposed sympathetic drive triggers a secondary brain insult that occurs hours to days after the primary TBI and manifests as systemic and intracranial hypertensions, abnormal heart rate variability, agitation, cerebral edema and cerebral hypo-perfusion to collectively cause the poor neuropsychological outcome. Opposing the sympathetic drive through neutralization of the catecholamine actions in TBI is therefore, a viable option for neuroprotection against a secondary brain insult. However, there is no clinical evidence from a prospective randomized trial demonstrating the safety and effectiveness of opposing the sympathetic drive after TBI.
Monitoring EEG in Comatose ICU Patients: A point prevalence observational study of intensive care unit experiences MECIP
Manuel M. Buitrago Blanco, MD, PhD
Non-convulsive seizures detected by continuous electroencephalography (cEEG) occur in about 30% of patients in coma. cEEG is also indicated for aiding in management and prognosis of critically ill patients with brain injury. Societal guidelines recommend the use of cEEG monitoring in this population to better aid in their management, yet implementation remains challenging.
WorldwidE AssessmeNt of Separation of pAtients From ventilatry assistancE WEAN SAFE
Phillippe R. Bauer, MD, PhD
Successful weaning of patients from invasive mechanical ventilation represents a crucial step in the recovery process following severe respiratory failure, and is a key clinical challenge for ICU clinicians. Many of the serious complications of IMV are directly related to the duration of ventilation. Failure to successfully separate patients from IMV contributes directly to poorer patient outcomes: including longer duration of ventilation, longer length of stay in the ICU and in the hospital, and higher patient mortality. Patients spend a considerable amount of time in being liberated from invasive mechanical ventilation. The systematic utilization of approaches to reduce the duration of ventilation are therefore of fundamental importance.
VOLUME-CHASERS: Observation of Variation in Fluids Administered and Characterization of Vasopressor Requirements in Shock
JT Tina Chen, MD
While fluid resuscitation is a mainstay of treatment for most cases of shock, excessive volume resuscitation is associated with worse clinical outcomes. There are many studies that have shown that dynamic hemodynamic measurements can predict fluid responsiveness, but little is known as to their association with important clinical outcomes. The overall goal of VOLUME-CHASER is to conduct a multicenter, observational cohort study across a broad range of hospitals, including patients in the emergency department, ICU, and non-ICU areas, to determine the variability in shock resuscitation and modalities used to determine the amount of fluid and vasopressor administered. We will explore the possible outcome differences associated with this variability in practice.
Titration of Inspired Oxygen During Mechanical Ventilation Using Electronic Alerts via Electronic Health Records: A Multicenter Study
Sonal R. Pannu, MD, MS
Hyperoxia, defined as fraction of inspired oxygen (FIO2) of greater than 0.5, can be injurious, augments ventilator-associated lung injury, and is associated with higher mortality. Liberal oxygenation practices are also associated with increased mortality in subsets of critically ill patients with post-cardiac arrest, stroke, and traumatic brain injury. FIO2 is titrated via oxygen saturations (SpO2); however, there is often delay in reducing FIO2 despite adequate SpO2. Processes of ventilator weaning and liberation may be delayed with inadequate titration. Hyperoxia prevails in most ICU settings due to poor awareness of the adverse effects of even mild hyperoxia and fear that even mild or short duration of hypoxia could be life-threatening. Therefore, there is a critical need to institute measures to improve practice of FIO2 titration in a conservative range to maintain optimal oxygen saturation.
The plan is to conduct a step-wedge, clustered, randomized implementation by sequential adoption every three months in participating ICUs with concurrent controls available until all sites adopt the protocol.
The aims of the study are to:
Structure, Process, and Utilization of Intermediate Care in the United States
David N. Hager, MD, PhD
Intensive care resources are limited, while the number of patients needing intensive care is increasing. It was previously recognized that, among patients admitted to intensive care units (ICUs), many do not require intensive care but are admitted for close monitoring. Intermediate care units (IMCUs), also known as high-dependency units, step-down units, or progressive care units, were created to accommodate patients whose needs do not require intensive care but surpass the care and monitoring feasible on a general ward. Patients may be transitioned to an IMCU after being stabilized in an ICU or having worsened on a general ward or may be directly admitted from the emergency department or post-anesthesia care unit.
Over the last 20 years, billing for intermediate care and the prevalence of IMCUs have increased. However, the optimal staffing structure, physical layout, and admission guidelines for these units are not well-defined. This is complicated by regional needs, institutional missions, clinical expertise, and physical resources. This marked heterogeneity of IMCUs and the characteristics of the patients they serve has resulted in limited generalizability of IMCU patient outcomes and cost-effectiveness studies to date. A better understanding of IMCU organizational structure paired with patient outcomes would greatly inform the use of this level of care in the future.
This will be a study of variability in the structure and use of IMCUs in different regions and centers. We will survey centers to characterize the current structure of intermediate care in the United States.
Severe ARDS: Generating Evidence SAGE
Pauline K. Park, MD, FCCM
Approximately one-quarter of patients with acute respiratory distress syndrome (ARDS) develop severe hypoxemia (PaO2/FiO2 < 100). In large series, severe hypoxemia has been associated with high observed mortality rates, approximating 40-50%. The severity of hypoxia in the majority of these patients is established at initial presentation, suggesting an opportunity for early intervention. Development of strategies to reduce mortality is hampered by the difficulty of conducting randomized trials in this population.
While a number of interventions in ARDS have been shown in randomized, controlled trials to lead to improved outcomes, studies to date indicate that the use of these evidence-based practices is highly variable and inconsistent. At the same time, treatment modalities that are unproven remain commonly used in the management of ARDS.
The SAGE study was conducted to evaluate current US practice in management of severe ARDS, both to inform practicing clinicians and to form the basis for future research.
Objective: An assessment of early management of severe ARDS, including ventilator management and use of rescue therapy.
Oral Midodrine Hydrochloride in Early Sepsis: Randomized, Double-Blind, and Placebo-Controlled Feasibility Study
Rahul Kashyap, MBBS
The aim of this patient-centered study is to conduct a feasibility clinical trial on oral midodrine in early sepsis and to seek alternatives to minimize the burden of an ICU stay in these patients.
Sepsis is the second leading cause of death in medical intensive care units, carrying a mortality rate of between 25% and 30%. Cardiovascular compromise in sepsis manifests as hypotension due to arterial vasodilation between 25% and 30%. Cardiovascular compromise in sepsis manifests as hypotension due to arterial vasodilation. Hypotension can persist despite initial resuscitation, prompting additional fluid boluses and subsequent central venous catheterization for the infusion of intravenous vasopressor agents. Both excess fluid boluses and central venous catheterization may expose patients to risk, harms, and discomfort.
Midodrine is an oral vasopressor agent approved for treating orthostatic hypotension. Preliminary data during the past several years suggest a markedly increased off-label use as a vasopressor-sparing agent in critically ill patients. However, no randomized trials have been conducted to evaluate the safety and efficacy of this practice.
The central hypothesis is that administering oral midodrine to septic patients who have received initial fluid resuscitation and appropriate antimicrobial treatment will mitigate systemic hypotension and decrease the need for additional fluid and vasopressor use. The proposed multicenter pilot trial is necessary to test the feasibility of enrollment, appropriate population, timing, effect size to determine the need, and sample size for subsequent phase II pragmatic clinical trial.
Inhaled Versus Early Systemic Steroids for Treatment of Pneumonia (INVESST Pneumonia) INVESST
Emir Festic, MD, MS, FCCM
Inhaled Versus Early Systemic Steroids for Treatment of Pneumonia (INVESST Pneumonia) will be a multicenter, double-blind, placebo-controlled, three-arm randomized trial to compare the efficacy of early treatment with an inhaled corticosteroid combined with a beta-agonists versus systemic corticosteroids versus usual care for prevention of acute respiratory failure (ARF) requiring mechanical ventilation and, second, to reduce hospital length of stay in patients with severe pneumonia.
The three aims are to:
1. Test the efficacy of early treatment with an inhaled corticosteroid (budesonide, 0.5 mg) combined with a beta-agonist (formoterol, 20 µg) or systemic steroid (IV methylprednisolone, 0.5 mg/kg) versus usual care for the prevention of ARF
2. Compare the efficacy and side effect profiles of inhaled delivery of a corticosteroid combined with a beta-agonist versus systemic steroids in regard to hospital length of stay, duration of need for supplemental oxygen, hyperglycemia, and arrhythmias
3. Identify biologic pathways associated with progression to ARF in patients with pneumonia and explore the effect of systemic versus inhaled delivery of corticosteroids on peripheral markers of inflammation (IL-6 and CRP), inflammasome activation (IL-18), and markers of endothelial (Ang-2) and epithelial (RAGE) lung injury.
High-Flow Oxygen Versus Positive Pressure Ventilation in the Emergency Department Program USCIIT-HOPE
Jarrod M. Mosier, MD, FCCM
The management of acute hypoxemic respiratory failure (AHRF) in the emergency department (ED) is difficult because of resource and logistical challenges. This is particularly true in patients with, or at risk for, acute lung injury. Many clinicians prefer treating these patients with noninvasive positive pressure ventilation (NIPPV) with the goals of preventing the need for deep sedation and invasive mechanical ventilation. More recently, a newer and potentially more efficacious therapy has been introduced: high-flow nasal cannula (HFNC) with a heated, humidified circuit and adjustable fraction of inspired oxygen with flows between 40 and 60 liters per minute. Recent studies have shown that HFNC might be superior for patients with AHRF in the intensive care unit. However, the utility of starting this therapy earlier in the disease course—in the ED—is unknown.
Although the mechanistic basis for any superiority of HFNC over NIPPV is unclear, presumably HFNC reduces lung injury by maintaining a lower transpulmonary pressure gradient and more lung-protective tidal volumes than NIPPV in spontaneously breathing patients with airspace disease. Thus, earlier initiation of this therapy in the ED would provide a greater benefit.
The overall goal of our research is to design a prospective multicenter randomized controlled trial to compare the rate of intubation at 72 hours for HFNC and NIPPV in adult ED patients with AHRF. The three specific aims are to:
1. Determine the failure rates (rate of intubation) of each therapy to adequately power a multicenter trial
2. Compare rates of intubation in ED patients with AHRF treated with either HFNC or NIPPV
3. Assess lung injury and inflammation in these patients before, during, and after treatment with either FHNC or NIPPV
Feasibility and Impact of Structured Telemedicine-Focused Strategy for End-of-Life Discussion During ICU Phase of Critical Illness
Sanjay Subramanian, MD
Acquiring an understanding of patient care goals in the context of a serious illness is an essential element of high-quality care, allowing clinicians to align the care provided with what is most important to the patient and family. Evidence indicates an increase in moral distress for critical care clinicians delivering futile care. Early discussions about goals of care are associated with better quality of life, reduced use of nonbeneficial medical care near death, enhanced goal-consistent care, positive family outcomes, reduced costs, and reduced clinician emotional exhaustion.
We aim to study the feasibility and impact of using a structured telemedicine strategy to initiate discussion and implement a plan for goals of care in the first 24 to 48 hours of septic shock after admission to the ICU.
Development and implementation of clinical predication models for seizures during post-cardiac arrest care
Teresa May, DO, MS
Cardiac arrest is a major public health problem, affecting more than 500,000 Americans annually. Approximately 100,000 of these patients survive cardiopulmonary resuscitation and are admitted to hospitals, where they are treated in intensive care units (ICUs). Despite this specialized care, the hospital mortality rates of these cardiac arrest survivors are high, ranging from 20% to 60%. Most of these deaths are caused by a brain injury known as hypoxic-ischemic encephalopathy (HIE), which results from inadequate blood flow to the brain during the arrest. HIE is accompanied by a high frequency of seizures, which are thought to exacerbate the acute brain damage caused by the arrest. Prevention of seizures after cardiac arrest is an important and novel treatment target with considerable potential to improve outcomes in this vulnerable population.
The aims of the research are to: 1) develop a clinical predication model of post-anoxic seizures to identify patients at risk for seizures at the time of hospital admission for a cardiac arrest using the existing International Cardiac Arrest Registry (INTCAR) database, 2) validate the prediction model using the INTCAR neurology subset of patients collected after 2018, 3) develop a predication model of existing data from 1,987 patients with cardiac arrest who were monitored on continuous EEG in INTCAR from 2008 to May 2017 to identify patients most likely to develop seizures, 4) validate the model on non-overlapping patients undergoing EEG from the INTCAR-neuro collected after May 2017, 5) develop a seizure predication interface using an electronic health record (EHR)-based tool easily accessible at the time of hospital admission, and 6) disseminating it at five centers to evaluate its utility in the clinical setting.
The overall goal of this research is to facilitate the established INTCAR neurology prospective data collection and assist in the selection of centers and implementation of an EHR prediction tool. The concepts and expertise learned though this project will be readily applicable to other disease decisions in both cardiac arrest and the neuro-ICU.
Recovery from acute kidney injury requiring dialysis: incidence, timeline, and risk prediction models
Javier Neyra, MD, MSCS
Acute kidney kidney injury (AKI) is a complex systemic syndrome associated with high morbidity and mortality. More than 5 million patients are admitted to hospital intensive care units (ICUs) each year in the United States. Approximately 10% of these patients have AKI requiring dialysis (AKI-D). Effective January 1, 2017, healthcare law has included a provision on coverage and payment for “outpatient renal dialysis services for individuals with AKI.” This legislation constitutes a timely and needed change in practice because it is estimated that a significant proportion of AKI-D survivors can sufficiently recover renal function (without needing dialysis) within the first 90 days after the initial insult. Therefore, there is an urgent need to characterize the biological natural course of AKI-D recovery and to develop clinical risk prediction models to identify those patients at high risk for not significantly recovering kidney function by the time of hospital discharge.
In this context, we propose a multicenter collaborative registry study in the ICU to 1) determine the incidence and timeline occurrence of AKI-D recovery, 2) determine clinical parameters associated with AKI-D recovery, and 3) develop and validate risk prediction models of AKI-D recovery. Our proposed study is a critical step for the development of post-AKI risk stratification tools and the identification of best practices for the optimal care of AKI-D survivors.
Programs for Emergency Preparedness PREP
J. Perren Cobb, BA, MD, FCCM
The appropriate treatment of critically ill or injured patients can vary from minute to minute. Thus, timely access to reliable data is one of the foundations of contemporary intensive care. It follows that optimal responses during public health emergencies, for both clinicians and decision-makers, would benefit from comprehensive, real-time event reporting. This should include physiologic patient data that are needed to provide immediate insight into the impact of the event on critical healthcare resources and to identify groups at high risk for morbidity and mortality. The Program for Emergency Preparedness (PREP) has as its goal to significantly enhance the national capability to rapidly glean crucial information regarding the clinical course of acute illness and injury and guide clinical resource requirements during emergent events through the following six aims:
Prevention Of Organ Failure PROOF
Michelle Ng Gong, MD
The PReventions Of Organ Failure (PROOF) program is composed of critical care researchers, represented by a multidisciplinary group of critical care specialists from anesthesia, emergency medicine, internal medicine, pulmonary, surgery, and trauma, who are interested in the prevention of injuries and diseases and their progression in the critically ill population.
Projects Conducted Under PROOF:
Practices Surrounding the Identification, Prevention, and Treatment of Delirium in the ICU
Amy L. Dzierba, PharmD, BCPS, FCCM
This investigation aims to describe the practices of detection, prevention, and treatment of delirium in adult ICU patients across institutions and to compare the perceived and actual activities surrounding detection, prevention, and treatment activities in a snapshot. This study will provide ICU clinicians, hospital administrators, and researchers with information on discrepancies between actual patient care and recently published evidence-based guideline recommendations.
Critical Illness Outcomes Study CIOS
Jonathan E. Sevransky, MD, FCCM
Variations in both structure and process are known to affect clinical outcomes in intensive care units (ICUs). With both increasing demand and increasing costs of adult critical care, it is important to understand how to best reduce variations in care. The Critical Illness Outcomes Study (CIOS) was designed to characterize the organizational structure, processes of care, use of protocols, and outcomes of ICUs, and to determine which of these structural and process-of-care factors might be associated with outcomes such as inpatient mortality.
Of the 94 U.S. ICUs we approached, 69 are participating in the study: 25 (36%) are medical; 24 (35%), surgical; and 20 (29%), mixed. We surveyed the 69 ICUs about their organization, size, volume, staffing, processes of care, and use of protocols, and investigated the relationship of structure and process to ICU mortality.
We collected patient demographic and treatment information one day each week until at least 100 patients were enrolled in each participating ICU. We have completed enrollment, with more than 6,400 patients, and are currently validating the data collected. CIOS is planning a second study to better determine which factors might be associated with high-performing ICUs.
Checklist for Early Recognition and Treatment of Acute Illness and Injury CERTAIN
Rahul Kashyap, MBBS
The Checklist for Early Recognition and Treatment of Acute Illness and iNjury (CERTAIN) is designed to standardize the approach to the evaluation and treatment of acutely decompensating patients. The design and content was informed by the survey of clinicians from diverse international settings. Available in electronic (laptop/mobile) and paper formats, CERTAIN provides evidence-based diagnostic checklists, clinical decision support, educational modules on performing critical procedures, and the ability to time and document real-time interventions.
A Multicenter Study to Evaluate Predictive Factors for Multidrug-Resistant Healthcare-Associated Pneumonia in Critically Ill Patients (DEFINE) DEFINE
Ishaq Lat, PharmD, FCCM
Pneumonia is a leading cause of death in the United States and is associated with significant costs to the healthcare system. Increasing rates of multidrug-resistant (MDR) pathogens challenge critical care clinicians to provide effective antimicrobial therapy while preserving the armamentarium of effective therapies. Literature describing the incidence and epidemiology of MDR pneumonia in the United States is limited. We conducted this study across 35 U.S. sites to elucidate the incidence of MDR pneumonia in the critical care setting.