Can Respiratory Rate Predict the Risk of Deterioration of Septic Patients
The primary objective is to determine if the trend in Respiratory Rate measurements provided by the device under investigation can be used to predict an increase in Sequential/Sepsis-related Organ Failure Assessment (SOFA) score.
The RR trend will be measured as the difference between the RR recorded by the device at a point 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The primary objective is to determine if the trend in Respiratory Rate measurements provided by the device under investigation can be used to predict an increase in Sequential/Sepsis-related Organ Failure Assessment (SOFA) score.
The RR trend will be measured as the difference between the RR recorded by the device at a point 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.
Secondary objective The secondary objective is to test if Respiratory Rate can help identify patients at increased risk of 30 day mortality.
The null Hypotheses of the planned comparison is that there is no difference in the RR trend in the 3 hours following commencement of treatment for sepsis in subjects who have an increase in SOFA score by 2 or more points and those who have a change in SOFA score of +1 or less.
The change in SOFA score will be measured at point of commencement of treatment and at 6 hours following commencement of treatment, or nearest available SOFA score determination.
Respiratory Rate captured during admission could have a predictive course for cohort of interest
The time points for reviewing the RR will be as follows:
(i) The last measurement (ii) The trend over 3 hours following commencement of treatment as per the standard of care for patients suspected of being septic.
(iii) The trend over the entire duration of admission
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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South West Jutland
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Esbjerg, South West Jutland, Dinamarca, DK-6700
- Hospital of South West Jutland, Department of Emergency Medicine
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion criteria
- ≥ 18 Years
- Admitted for a minimum of 12 hours
- Have been diagnosed with sepsis
Sepsis diagnosis confirmed by documented or suspected infection (ordering of blood culture or other microbiological investigation by the clinician) and ≥1 of the following presenting within the first 4 hours of admission:
- Fever or hypothermia, Core temperature > 38.3 or < 36 °C
- Heart rate > 90/min
- Respiratory rate > 20/min
- Altered consciousness/mental state, defined as GCS < 15
- Hyperglycemia, (BS > 6.7 mmol/L non-diabetic)
- LKC > 12 *10^9 or < 4*10^9,
- Normal LKC with > 10 % immature cells,
- CRP > highest normal local lab. Interval
- Hypotension: Systolic BP <90 mmHg, or drop in systolic BP > 40
- Hypoxemia: PaO2 < 8.5 Kpa or PaO2/FiO2 < 40 or tissue perfusion: P-lactate > 1.6
- Creatinine . 177 µmol/L
- Acute oliguria (Diuresis per hour ,0.5 ml/kg/t or 45 ml/t in 2 hours)
- Coagulopathy: Spontaneous INR > 1.5, or apt > 60 sec, thrombocytopenia
- Paralytic ileus (absence of bowel sounds)
- Hyperbilirubinemia > 34µmol/L
- Are willing to voluntarily sign a statement of informed consent to participate in this investigation
Exclusion criteria
- Allergic to medical grade skin adhesive
- Pregnant women during second and third trimester
- Continuous long term steroid use. Defined as not using steroids in the 4 weeks previous to enrolment
- Patients under the influence of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
- Any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent. This will be determined by the Abbreviated Mental Test Score (AMT) Cannot be followed a second time if admitted again at a later date during the study period
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Suspicion of Sepsis
Patients who are admitted and are diagnosed with sepsis will be recruited for this investigation.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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RespiraSense triggered escalation in SOFA score
Periodo de tiempo: 15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.
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Escalation of SOFA score by 2 or more points.
The primary endpoint will be evaluated with an ANCOVA with escalation of SOFA score by 2 or more points as a factor and mean RR in the first hour of treatment as a covariate.
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15 minutes after commencement of treatment, as per the standard of care for patients suspected of being septic, and a point 3 hours following this.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Upward trend in Respiratory Rate as a predictor of 30 day mortality
Periodo de tiempo: 30 days after discharge
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The secondary endpoint is the 30 day mortality rate after discharge.
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30 days after discharge
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Upward trend in Respiratory Rate as a predictor of 30 day readmission.
Periodo de tiempo: 30 days after discharge
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The secondary endpoint is the 30 day readmission rate after discharge.
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30 days after discharge
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- PMD-CS-006ii
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Septicemia
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University of California, San FranciscoNational Cancer Institute (NCI)ReclutamientoSepticemia | Sepsis, Severa | Sepsis y Choque Séptico | Sepsis en Unidad de Cuidados Intensivos | Sepsis, Choque Séptico | Sepsis, Sepsis Severa y Shock Séptico | Sepsis con disfunción orgánica múltiple (MOD) | Sepsis con disfunción orgánica agudaEstados Unidos
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Assiut UniversityAún no reclutandoDisfunción miocárdica inducida por sepsis | Miocardiopatía inducida por sepsisEgipto
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University of Kansas Medical CenterUniversity of KansasReclutamientoSepticemia | Shock séptico | Síndrome de sepsis | Sepsis, Severa | Sepsis bacteriana | Sepsis BacteriemiaEstados Unidos
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Jip GroenInBiomeReclutamientoColonización Microbiana | Infeccion Neonatal | Sepsis Neonatal, Inicio Temprano | Enfermedad microbiana | Sepsis clínica | Sepsis neonatal con cultivo negativo | Sepsis Neonatal, Inicio Tardío | Sepsis neonatal con cultivo positivoPaíses Bajos
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Indonesia UniversityTerminadoImpacto del tratamiento con heparina no fraccionada en dosis bajas sobre la inflamación en la sepsisSepsis severa con shock séptico | Sepsis severa sin shock sépticoIndonesia
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London Health Sciences Centre Research Institute...Reclutamiento
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Carol Davila University of Medicine and PharmacyReclutamiento
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Assiut UniversityAún no reclutandoSepsis en Pacientes de UrgenciasEgipto
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Firat UniversityTerminadoSepsis - para Reducir la Mortalidad en la Unidad de Cuidados Intensivos | Biomarcador de Sepsis | Regulación Molecular a la Baja de Fenixina-14Turquía (Türkiye)