NCT07803263

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Oct 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Nov 2027

First Submitted

Initial submission to the registry

August 31, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 31, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

Pediatric Intensive Care UnitPICUArterial Blood GasAcidemiaBase DeficitSerum BicarbonatePediatric Critical CareMortality

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Metabolic Acidosis on Admission

    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

Study Arms (1)

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.

Eligibility Criteria

Age1 Month - 1 Year
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients aged 1 month up to 18 years admitted to the Pediatric Intensive Care Unit (PICU) at Assiut University Children Hospital during the study period who undergo arterial blood gas (ABG) analysis upon admission.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AcidosisAcid-Base Imbalance

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Pediatrics

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 3, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

September 3, 2026

Record last verified: 2026-08