Electrolytes Disturbances in Critically Ill Egyptian Patients

The Incidence, Risk Factors and Outcomes of Electrolytes Disturbances in Critically Ill Egyptian Patients: A Single-Centre Prospective Cohort Study

All selected individuals will be subjected to the following:

1. Full medical history taking
2. Full clinical examination, APACHE II score on admission
3. Electrolytes pannel daily on ICU admission
4. Estimate the duration of stay at ICU Also all selected individuals will be sectioned into groups regarding sites of collection (surgical ICU, CCU and medical ICU). All collected individuals will be sectioned regarding electrolytes imbalance into mild, moderate and severe groups

Study Overview

• Status: Enrolling by invitation
• Conditions: Electrolyte Imbalance
• Intervention / Treatment: Other: electrolytes - serum blood samples

Detailed Description

Study Procedures: All selected individuals will be suffering from electrolyte imbalance (EI) with the following data will be obtained:

o Measurements:

1. Demographic data: age - gender - BMI - electrolytes data on ICU admission
2. Vital data: heart rate - respiratory rate - blood pressure measurement - Oxygen saturation - Urinary output - Temp +/- CVP measurement.
3. Lab.: "CBC - Kidney function tests - liver function tests - ABG - levels of serum sodium, potassium, magnesium, phosphorus, ionized calcium and chloride", with maximum 5 mm blood sampling per day. Serum-sodium levels will be corrected for serum-glucose by lowering the sodium concentration by 2.4 mmol/L for every 100 mg/dl increase in glucose. Corrected Sodium = Measured sodium + 0.016 (Serum glucose - 100) A correction formula was also used to calculate albumin-corrected calcium levels (mmol/L) Corrected Calcium = (0.8 (Normal Albumin - Pt's Albumin)) + Serum Ca
4. APACHE II score
5. Comorbidities
6. Complications: AKI- Acute myocardial infarction
7. Duration of ICU stay
8. Duration of hospital stay
9. Outcome (regarding eventual complications: AKI- Acute myocardial infarction)

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 7154411
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

critically ill Egyptian patients

Description

Inclusion Criteria:

- All patients admitted to medical ICU, surgical ICU and CCU suffering from electrolyte imbalance (EI) over 18 years with the comorbid conditions :

1. Hypertension
2. Heart failure
3. Chronic chest diseases
4. Cancers
5. Chronic kidney disease
6. Diabetes mellitus
7. Cardiac dysrhythmias
8. Pneumonia
9. Sepsis
10. Dehydration
11. Critical bones fractures

Exclusion Criteria:

• Patients with

  1. Age less than 18 year old
  2. Patient or his 1st degree relatives refuse to participate
  3. Patients without electrolytes data
  4. Current smoking

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
impact of electrolytes imbalances for general health status	Laboratory: levels of serum sodium "mmol/L", potassium "mmol/L", magnesium "mg/dl", phosphorus "mg/dl", ionized calcium "mmol/L" and chloride "mmol/L", with maximum 5 mm blood sampling per day. Serum-sodium levels will be corrected for serum-glucose by lowering the sodium concentration by 2.4 mmol/L for every 100 mg/dl increase in glucose. Corrected Sodium = Measured sodium + 0.016 (Serum glucose - 100). A correction formula was also used to calculate albumin-corrected calcium levels (mmol/L). Corrected Calcium = (0.8 (Normal Albumin - Pt's Albumin)) + Serum Ca	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
impact of electrolytes imbalances for hospital stay	calculation of hospital admission days and correlations with records of serum electrolytes results per admission	1 year

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Michael Sadek, MD candidate, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Estimated): June 3, 2024
• Study Completion (Estimated): August 17, 2024

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 20, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Egyptian; Electrolytes
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: FMASU MD195/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No