CLEAR SepsisNoninvasive Hemodynamic Monitoring Utilizing ClearSight TM System in Suspected Sepsis Patients Presenting to the Emergency Department (CLEAR SEPSIS)
Colección de datos
Recopilados desde hoy en adelante - ProspectivoInflamación+1
+ Infecciones
+ Procesos Patológicos
Casos y Controles
Examen de las características de personas con una enfermedad para identificar factores genéticos o ambientales que contribuyen a la condición.Resumen
Fecha de inicio: 29 de junio de 2017
Fecha en la que se inscribió al primer participante.To investigate the relationship between initial ClearSight™ derived hemodynamic parameters and outcomes (death, ongoing organ dysfunction or delayed ICU admission) in patients with acute infection and possible sepsis, with a focus on venous blood lactate (< 2.0, 2.0-3.9, and ≥ 4.0 mmol/dL) and hemodynamic subgroups, using ED patients presenting with minor infections or asthma/COPD exacerbations as controls (henceforth referred to as Sepsis Mimic Group).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 182 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Casos y Controles
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Venous Blood Lactate Groups Inclusion Criteria: * ≥ 18 years of age at the time of enrollment * Any combination of acute symptoms and signs that the treating ED physician, after initial history and physical examination, attributes to a systemic infection * ED Physician confirms likely hospital admission (\> 50%) due to suspicion of infection * ED Physician confirms intention to order both blood cultures and venous blood lactate levels * Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation Exclusion Criteria: * Initial venous blood lactate measured \> 3 hours after ED arrival * Pre-existing infection for which patient is being treated with antibiotics as an outpatient * Prisoners * Pregnant women * Any previous medical condition with life expectancy of \< 3 months (patients with ESRD and heart failure are not excluded) * DNR or comfort care order preexisting to ED visit or established in the ED * Palliative care or hospice consult in the ED * Known severe aortic insufficiency * Known history of Raynaud's disease * Poor follow-up candidate in the opinion of the Investigator * Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection. Control Sepsis Mimic Inclusion Criteria: * ≥18 years of age at the time of enrollment * Presents to the ED with a chief complaint consistent with a minor infection (upper respiratory infection, soft tissue infection, viral infection) or an asthma or COPD exacerbation on whom the treating physician is not ordering labs for blood cultures or lactate levels * Ability to enroll patient and begin ClearSight™ monitoring within three (3) hours of ED presentation. Exclusion Criteria: * Pre-existing infection for which patient is being treated with antibiotics as an outpatient * Prisoners * Pregnant women * Any previous medical condition with life expectancy of \< 3 months (patients with ESRD and heart failure are not excluded) * DNR or comfort care order preexisting to ED visit or established in the ED * Palliative care or hospice consult in the ED * Known severe aortic insufficiency * Known history of Raynaud's disease * Poor follow-up candidate in the opinion of the Investigator * Current or planned enrollment in an investigational trial that in the opinion of the Investigator may significantly affect hemodynamic data collection. * Treating physician is planning on ordering either a lactate or blood cultures on the patient.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 5 ubicaciones
Sinai-Grace Hospital
Detroit, United StatesAscension St. John Hospital
Detroit, United StatesBeaumont Hospital, Royal Oak
Royal Oak, United States