Electrolytes AbnormalitiesNCT07205562
Serum Electrolyte Abnormalities as Prognostic Factor for Outcome in Critically Ill Children
An observational study of Electrolytes Abnormalities and Children, run by Assiut University.
Trial summary
The aim of this study is to evaluate the clinical profile and outcome of children with serum electrolyte abnormalities admitted at Pediatric Intensive Care Unit in Assuit University Children Hospital. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Electrolytes Abnormalities, Children, Prognostic Factors
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 2026
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will include critically ill children admitted to the Pediatric Intensive Care Unit (PICU) at Assiut University Children's Hospital who are found to have serum electrolyte abnormalities during their admission. Patients will be enrolled consecutively over the study period, regardless of gender, aged from 1 month to 18 years.
Who may be able to join
- Children aged 1 month to 18 years.
- Admission to the PICU for any acute medical or surgical reason.
- Availability of serum electrolyte data within the first 24 hours of admission
Who cannot join
- Children with known chronic kidney disease and chronic liver disease
- Patients with incomplete medical records or missing electrolyte data.
- Children discharged or deceased within 6 hours of admission.
- Patients with chronic liver diseases, or previously diagnosed with adrenal gland disorders
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to evaluate the clinical profile and outcome of children with serum electrolyte abnormalities admitted at Pediatric Intensive Care Unit in Assuit University Children Hospital.
Read the detailed description
Electrolyte imbalances are frequent and potentially life-threatening disturbances encountered in pediatric intensive care units (PICUs). These imbalances can reflect underlying pathological processes, treatment interventions, or both, and may influence the clinical course and outcomes of critically ill children. The homeostasis of electrolytes such as sodium, potassium, calcium, and magnesium plays a central role in cellular function, nerve conduction, and cardiovascular stability, making their monitoring and correction crucial during pediatric critical illness .
Studies have highlighted that disturbances like hyponatremia, hyperkalemia, or hypocalcemia often serve as early indicators of disease severity or progression. Kiran and Chaudhary[2021]observed that children admitted with electrolyte abnormalities frequently experienced higher morbidity and mortality compared to those without such disturbances, suggesting a direct correlation with outcomes in the PICU setting .
These abnormalities may arise from diverse etiologies, including dehydration, renal dysfunction, endocrinal disorder and hypothalamic disorder, sepsis, gastrointestinal losses, or medication effects Electrolyte derangements are particularly prevalent among pediatric patients presenting to emergency departments, with age-related differences in presentation and underlying causes. Yen et al. demonstrated that younger children were more prone to sodium and potassium imbalances due to immature renal handling and higher fluid turnover, while older children exhibited abnormalities associated with chronic illnesses or pharmacological agents .Recognizing these patterns can aid in risk stratification and individualized management strategies The spectrum of electrolyte emergencies in children is broad and necessitates rapid identification and intervention. Zieg et al. underscored that life-threatening complications such as arrhythmias, seizures, and cerebral edema often arise from untreated or mismanaged electrolyte disorders, especially in the PICU environment . Hence, early diagnosis and understanding of etiological factors are pivotal in improving clinical outcomes and preventing complications.
Local demographic and regional healthcare factors may also influence the incidence and types of electrolyte abnormalities. In a study from a tertiary care center, Routray et al. found significant variation in electrolyte imbalance profiles across different age groups and disease categories, emphasizing the importance of context-specific evaluation in pediatric populations . Such data are essential for tailoring protocols in resource-limited settings Recent studies such as the one by Rewers et al. on diabetic ketoacidosis have demonstrated that fluid rehydration strategies can impact the rate of correction of acidosis and electrolyte derangements. Their findings highlighted the importance of fluid composition and timing in achieving rapid stabilization without causing further complications . Such protocols are particularly relevant in pediatric patients with metabolic derangements Finally, the overall impact of electrolyte disorders on mortality in the PICU has been underscored in several investigations. Haider et al. found a statistically significant association between electrolyte imbalance and increased risk of death among critically ill children, stressing the need for early intervention and continuous monitoring as part of comprehensive PICU care .
- Conditions
- Electrolytes Abnormalities, Children, Prognostic Factors
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Correlation of Electrolyte Abnormalities With PICU Mortality
To determine the frequency and distribution of electrolyte abnormalities (sodium, potassium, calcium, magnesium, phosphate, and chloride) in critically ill children admitted to the PICU, and to evaluate their correlation with PICU mortality.
Measured: average of hospital stay: up to 28 days
Secondary outcomes (1)
Risk Factors and Clinical Outcomes Correlated With Electrolyte Abnormalities in PICU Patients
To identify potentially modifiable risk factors for developing electrolyte abnormalities in critically ill children admitted to the PICU, and to evaluate their correlation with adverse clinical outcomes, including prolonged PICU stay, need for mechanical ventilation, and morbidity indicators (seizures, arrhythmias, altered mental status).
Measured: average hospital stay: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Electrolytes AbnormalitiesStudies 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennatullah Ahmed Hussein Abdelbary, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205562
- Sponsor's protocol ID
- Serum Electrolyte Disorders
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Raza M, Kumar S, Ejaz M, Azim D, Azizullah S, Hussain A. Electrolyte Imbalance in Children With Severe Acute Malnutrition at a Tertiary Care Hospital in Pakistan: A Cross-Sectional Study. Cureus. 2020 Sep 19;12(9):e10541. doi: 10.7759/cureus.10541.
PubMed 33094080Rewers A, Kuppermann N, Stoner MJ, Garro A, Bennett JE, Quayle KS, Schunk JE, Myers SR, McManemy JK, Nigrovic LE, Trainor JL, Tzimenatos L, Kwok MY, Brown KM, Olsen CS, Casper TC, Ghetti S, Glaser NS; Pediatric Emergency Care Applied Research Network (PECARN) FLUID Study Group. Effects of Fluid Rehydration Strategy on Correction of Acidosis and Electrolyte Abnormalities in Children With Diabetic Ketoacidosis. Diabetes Care. 2021 Sep;44(9):2061-2068. doi: 10.2337/dc20-3113. Epub 2021 Jun 29.
PubMed 34187840Zieg J, Ghose S, Raina R. Electrolyte disorders related emergencies in children. BMC Nephrol. 2024 Aug 30;25(1):282. doi: 10.1186/s12882-024-03725-5.
PubMed 39215244Subba Rao SD, Thomas B. Electrolyte abnormalities in children admitted to pediatric intensive care unit. Indian Pediatr. 2000 Dec;37(12):1348-53. No abstract available.
PubMed 11119337
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Electrolyte Abnormalities as Prognostic Factor for Outcome in Critically Ill Children
- ClinicalTrials.gov ID
- NCT07205562
- Acronym / sponsor ID
- Serum Electrolyte Disorders
- Conditions
- Electrolytes Abnormalities, Children, Prognostic Factors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Oct 2025 (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.
The aim of this study is to evaluate the clinical profile and outcome of children with serum electrolyte abnormalities admitted at Pediatric Intensive Care Unit in Assuit University Children Hospital.
Detailed description
Electrolyte imbalances are frequent and potentially life-threatening disturbances encountered in pediatric intensive care units (PICUs). These imbalances can reflect underlying pathological processes, treatment interventions, or both, and may influence the clinical course and outcomes of critically ill children. The homeostasis of electrolytes such as sodium, potassium, calcium, and magnesium plays a central role in cellular function, nerve conduction, and cardiovascular stability, making their monitoring and correction crucial during pediatric critical illness .
Studies have highlighted that disturbances like hyponatremia, hyperkalemia, or hypocalcemia often serve as early indicators of disease severity or progression. Kiran and Chaudhary[2021]observed that children admitted with electrolyte abnormalities frequently experienced higher morbidity and mortality compared to those without such disturbances, suggesting a direct correlation with outcomes in the PICU setting .
These abnormalities may arise from diverse etiologies, including dehydration, renal dysfunction, endocrinal disorder and hypothalamic disorder, sepsis, gastrointestinal losses, or medication effects Electrolyte derangements are particularly prevalent among pediatric patients presenting to emergency departments, with age-related differences in presentation and underlying causes. Yen et al. demonstrated that younger children were more prone to sodium and potassium imbalances due to immature renal handling and higher fluid turnover, while older children exhibited abnormalities associated with chronic illnesses or pharmacological agents .Recognizing these patterns can aid in risk stratification and individualized management strategies The spectrum of electrolyte emergencies in children is broad and necessitates rapid identification and intervention. Zieg et al. underscored that life-threatening complications such as arrhythmias, seizures, and cerebral edema often arise from untreated or mismanaged electrolyte disorders, especially in the PICU environment . Hence, early diagnosis and understanding of etiological factors are pivotal in improving clinical outcomes and preventing complications.
Local demographic and regional healthcare factors may also influence the incidence and types of electrolyte abnormalities. In a study from a tertiary care center, Routray et al. found significant variation in electrolyte imbalance profiles across different age groups and disease categories, emphasizing the importance of context-specific evaluation in pediatric populations . Such data are essential for tailoring protocols in resource-limited settings Recent studies such as the one by Rewers et al. on diabetic ketoacidosis have demonstrated that fluid rehydration strategies can impact the rate of correction of acidosis and electrolyte derangements. Their findings highlighted the importance of fluid composition and timing in achieving rapid stabilization without causing further complications . Such protocols are particularly relevant in pediatric patients with metabolic derangements Finally, the overall impact of electrolyte disorders on mortality in the PICU has been underscored in several investigations. Haider et al. found a statistically significant association between electrolyte imbalance and increased risk of death among critically ill children, stressing the need for early intervention and continuous monitoring as part of comprehensive PICU care .
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will include critically ill children admitted to the Pediatric Intensive Care Unit (PICU) at Assiut University Children's Hospital who are found to have serum electrolyte abnormalities during their admission. Patients will be enrolled consecutively over the study period, regardless of gender, aged from 1 month to 18 years.
Key inclusion criteria (3 listed)
- Children aged 1 month to 18 years.
- Admission to the PICU for any acute medical or surgical reason.
- Availability of serum electrolyte data within the first 24 hours of admission
Key exclusion criteria (4 listed)
- Children with known chronic kidney disease and chronic liver disease
- Patients with incomplete medical records or missing electrolyte data.
- Children discharged or deceased within 6 hours of admission.
- Patients with chronic liver diseases, or previously diagnosed with adrenal gland disorders
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
Incidence and Correlation of Electrolyte Abnormalities With PICU Mortality
Time frame: average of hospital stay: up to 28 days
To determine the frequency and distribution of electrolyte abnormalities (sodium, potassium, calcium, magnesium, phosphate, and chloride) in critically ill children admitted to the PICU, and to evaluate their correlation with PICU mortality.
1 secondary outcome
Risk Factors and Clinical Outcomes Correlated With Electrolyte Abnormalities in PICU Patients
Time frame: average hospital stay: up to 28 days
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 Oct 2025.
- Results publication: PubMed 33094080Raza M, Kumar S, Ejaz M, Azim D, Azizullah S, Hussain A. Electrolyte Imbalance in Children With Severe Acute Malnutrition at a Tertiary Care Hospital in Pakistan: A Cross-Sectional Study. Cureus. 2020 Sep 19;12(9):e10541. doi: 10.7759/cureus.10541.
- Results publication: PubMed 34187840Rewers A, Kuppermann N, Stoner MJ, Garro A, Bennett JE, Quayle KS, Schunk JE, Myers SR, McManemy JK, Nigrovic LE, Trainor JL, Tzimenatos L, Kwok MY, Brown KM, Olsen CS, Casper TC, Ghetti S, Glaser NS; Pediatric Emergency Care Applied Research Network (PECARN) FLUID Study Group. Effects of Fluid Rehydration Strategy on Correction of Acidosis and Electrolyte Abnormalities in Children With Diabetic Ketoacidosis. Diabetes Care. 2021 Sep;44(9):2061-2068. doi: 10.2337/dc20-3113. Epub 2021 Jun 29.
- Results publication: PubMed 39215244Zieg J, Ghose S, Raina R. Electrolyte disorders related emergencies in children. BMC Nephrol. 2024 Aug 30;25(1):282. doi: 10.1186/s12882-024-03725-5.
- Results publication: PubMed 11119337Subba Rao SD, Thomas B. Electrolyte abnormalities in children admitted to pediatric intensive care unit. Indian Pediatr. 2000 Dec;37(12):1348-53. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrolytes Abnormalities and Children, 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 Oct 2025. 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?
Contact Menna Allah Ahmed Hussein, Principal Investigator (+201092583368, Menna.17289766@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Correlation of Electrolyte Abnormalities With PICU Mortality (time frame: average of hospital stay: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07205562, which also lists 4 linked publications.
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 Oct 2025.