Serum Electrolyte Abnormalities as Prognostic Factor for Outcome in Critically Ill Children

NCT ID: NCT07205562

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Electrolytes Abnormalities Children Prognostic Factors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mennatullah Ahmed Hussein Abdelbary

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Menna Allah Ahmed Hussein, Principal Investigator

Role: CONTACT

+201092583368

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33094080 (View on PubMed)

Rewers 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.

Reference Type BACKGROUND
PMID: 34187840 (View on PubMed)

Zieg 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.

Reference Type BACKGROUND
PMID: 39215244 (View on PubMed)

Subba 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.

Reference Type BACKGROUND
PMID: 11119337 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Serum Electrolyte Disorders

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Efficient PICU Fluid Care Evaluation
NCT06644508 NOT_YET_RECRUITING NA