Electrolytes Disturbances in Critically Ill Egyptian Patients

Electrolyte Imbalance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06097104
• Other study ID #: FMASU MD195/2023
• Status: Enrolling by invitation
• Start date: September 26, 2023
• Est. completion date: August 17, 2024

Study information

• Verified date: April 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 110
• Est. completion date: August 17, 2024
• Est. primary completion date: June 3, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Electrolyte Imbalance

Intervention

Other:
• electrolytes - serum blood samples
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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	impact of electrolytes imbalances for hospital stay	calculation of hospital admission days and correlations with records of serum electrolytes results per admission	1 year