Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT06097104
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-08-05
First Post:
2023-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrolytes Disturbances in Critically Ill Egyptian Patients
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
The Incidence, Risk Factors and Outcomes of Electrolytes Disturbances in Critically Ill Egyptian Patients: A Single-Centre Prospective Cohort Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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)
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: