NCT07205562

Brief 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Oct 2025

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

September 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 17, 2025

Last Update Submit

September 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    average of hospital stay: up to 28 days

Secondary Outcomes (1)

  • Risk Factors and Clinical Outcomes Correlated With Electrolyte Abnormalities in PICU Patients

    average hospital stay: up to 28 days

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 33094080BACKGROUND
  • 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.

    PMID: 34187840BACKGROUND
  • 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.

    PMID: 39215244BACKGROUND
  • 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.

    PMID: 11119337BACKGROUND

Central Study Contacts

Menna Allah Ahmed Hussein, Principal Investigator

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 17, 2025

First Posted

October 3, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 3, 2025

Record last verified: 2025-09