- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07803263
Frequency of Metabolic Acidosis in the Pediatric Intensive Care Unit
Frequency of Metabolic Acidosis Among Patients Admitted to Pediatric Intensive Care Unit
Metabolic acidosis is one of the most common acid-base disturbances encountered in critically ill children and often reflects underlying disease severity. Despite its clinical importance, prospective epidemiological data regarding its frequency, underlying etiologies, and associated clinical outcomes among pediatric intensive care unit (PICU) admissions in Upper Egypt remain limited.
The primary objective of this prospective observational cohort study is to determine the frequency of metabolic acidosis among pediatric patients admitted to the Pediatric Intensive Care Unit at Assiut University Children Hospital. Secondary objectives include identifying the common etiologies and types of metabolic acidosis, as well as evaluating its relationship with clinical outcomes such as mortality, duration of PICU stay, need for mechanical ventilation, and requirement for vasoactive support.
A total of 140 eligible pediatric patients aged 1 month to 18 years admitted to the PICU will be enrolled. Eligible patients will undergo arterial blood gas (ABG) analysis and standard clinical and laboratory evaluations upon admission. Metabolic acidosis will be defined based on admission ABG criteria (serum/arterial bicarbonate < 22 mmol/L and/or base deficit ≥ 5 mmol/L). Patients will be monitored throughout their hospital stay to assess clinical outcomes without interfering with routine medical management.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Pediatric patients aged 1 month up to 18 years.
- Admission to the Pediatric Intensive Care Unit (PICU).
- Arterial blood gas (ABG) analysis performed on admission.
Exclusion Criteria:
- Neonates (age < 1 month).
- Readmission during the same hospital admission.
- Patients with incomplete clinical or laboratory data.
- Patients discharged or transferred before complete initial clinical and laboratory assessment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
PICU Cohort
Critically ill pediatric patients aged 1 month up to 18 years admitted to the Pediatric Intensive Care Unit (PICU) who undergo arterial blood gas analysis upon admission.
Patients will be evaluated for the presence of metabolic acidosis and followed during their PICU stay to assess clinical outcomes, duration of stay, and mortality.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants With Metabolic Acidosis on Admission
Periodo de tiempo: Baseline
|
Metabolic acidosis is defined based on arterial blood gas (ABG) analysis performed at admission as a serum or arterial bicarbonate concentration less than 22 mmol/L and/or a base deficit greater than or equal to 5 mmol/L.
The outcome is measured as the percentage of participants meeting these criteria.
|
Baseline
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Metabolic Acidosis in PICU
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .