- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Participants With Metabolic Acidosis on Admission
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Metabolic Acidosis in PICU
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