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NCT Number: NCT07803263

Frequency of Metabolic Acidosis in the 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.

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Key information

Age range

1 month–1 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of Participants With Metabolic Acidosis on Admission

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Frequency of Metabolic Acidosis Among Patients Admitted to Pediatric Intensive Care Unit

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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