- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants With Metabolic Acidosis on Admission
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Metabolic Acidosis in PICU
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .