Clinical trial NCT06097104: Electrolytes Disturbances in Critically Ill Egyptian Patients
Official title: The Incidence, Risk Factors and Outcomes of Electrolytes Disturbances in Critically Ill Egyptian Patients: A Single-Centre Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Electrolyte Imbalance
Keywords: Electrolytes
Egyptian
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: critically ill Egyptian patients

Brief 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 panel 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

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)

Eligibility criteria: 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

Primary outcomes:
measure: impact of electrolytes imbalances for general health status
timeFrame: 1 year
Secondary outcomes:
measure: impact of electrolytes imbalances for hospital stay
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Michael Sadek, MD candidate
role: PRINCIPAL_INVESTIGATOR
References: