Metabolic AcidosisNCT07803263
Frequency of Metabolic Acidosis in the Pediatric Intensive Care Unit
An observational study of Metabolic Acidosis and Acid-Base Imbalance, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 1 year
- Conditions the study is for
- Metabolic Acidosis, Acid-Base Imbalance, Critical Illness in Children
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 1 year
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
- Keywords
- Pediatric Intensive Care Unit, PICU, Arterial Blood Gas, Acidemia, Base Deficit, Serum Bicarbonate, Pediatric Critical Care, Mortality
- Medical subject headings
- Acidosis, Acid-Base Imbalance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic AcidosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Yousry Adeeb Azer, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803263
- Sponsor's protocol ID
- Metabolic Acidosis in PICU
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Metabolic Acidosis Among Patients Admitted to Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07803263
- Acronym / sponsor ID
- Metabolic Acidosis in PICU
- Keywords
- Pediatric Intensive Care Unit, PICU, Arterial Blood Gas, Acidemia, Base Deficit, Serum Bicarbonate, Pediatric Critical Care, Mortality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 month to 1 year
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Acidosis and Acid-Base Imbalance, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Metabolic Acidosis on Admission (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.