The Incidence, Risk Factors and Outcomes of Electrolytes Disturbances in Critically Ill Egyptian Patients: A Single-Centre Prospective Cohort Study
Conditions: Electrolyte Imbalance
Sponsor: Ain Shams University

  
NCT06097104 
Date of Document 
26.9.2023 
 
 
 
 
 
 
 
 
The incidence, risk factors and outcomes of electrolytes  
disturbances in critically ill Egyptian Patients:  
A single-Centre Prospective Cohort Study 
 
 

  
NCT06097104 
Date of Document 
26.9.2023 
PROTOCOL OF A THESIS FOR PARTIAL FULLFILMENT  
OF M.D. DEGREE IN GENERAL INTENSIVE CARE UNIT 
 
Title of the Protocol:  
The incidence, risk factors and outcomes of electrolytes  
disturbances in critically ill Egyptian Patients:  
A single-Centre Prospective Cohort Study 
 
Postgraduate Student:   
Michael Mamdouh Anwar  
Degree:  
 
 
 
M.B.B.Ch., M.Sc. Ain Shams University.  
  
 DIRECTOR:  
 
 
Prof. Alaa Eid Mohammed 
Academic Position:  
 
Professor.  
Department:  
Anesthesia, Intensive Care and Pain Management, 
Faculty of Medicine, Ain Shams University.  
  
Co-DIRECTOR:   
 
Prof. Hanaa Mohamed Abdallah EL Gendy 
Academic Position:  
 
Professor.  
Department:  
Anesthesia, Intensive Care and Pain Management, 
Faculty of Medicine, Ain Shams University.  
  
Co-DIRECTOR:   
 
Dr. Doaa Mohammed Kamal EL-Din 
Academic Position:  
 
Lecturer.  
Department:  
Anesthesia, Intensive Care and Pain Management, 
Faculty of Medicine, Ain Shams University.  
Co-DIRECTOR:   
 
Dr. Eman Mohamed Hesham Khalyl EL-Shaer  
Academic Position:  
 
Lecturer.  
Department:  
Anesthesia, Intensive Care and Pain Management, 
Faculty of Medicine, Ain Shams University.  
 
 
Faculty of Medicine - Ain Shams University 
2023 

  
NCT06097104 
Date of Document 
26.9.2023 
What is already known on this subject? 
Electrolytes disorders are common in hospitalized patients and associated with 
increased morbidity and mortality. The combination of metabolic acidosis plus 
respiratory acidosis often occurs in critically ill patients with cardiac arrest, renal 
failure and severe congestive heart failure. 
 
1. INTRODUCTION: 
Electrolytes imbalance (EI) is common in hospitalized patients as well as in the 
general population and is associated with increased morbidity and mortality 1–9. 
Clinically 
important 
EIs 
include 
dysnatremia, 
dyskalemia, 
dyscalcemia, 
dysmagnesemia, and dysphosphatemia.  
Electrolyte disorders are defined as an altered level of the following at least 
one of the electrolytes (potassium, chloride, sodium, or calcium level, magnesium and 
phosphorus), that is, either increasing or decreasing from the normal range. The 
following ranges are used to determine the imbalance for each electrolyte: Na+= 135-
145 mmol/L, K+= 3.5-5.5 mmol/L, Ca2+ = 2.1-2.55 mmol/L, and Cl− = 98-108 
mmol/L, Mg+2 = 1.6-2.5 mg/dl, PO4- = 1.12-1.45 mg/dl.  10 
EIs have previously been investigated in several different cohorts. However, most 
previous studies have investigated one or two specific electrolytes in a selected group of 
patients with a single disease (e.g., heart or kidney disease) 11 - 13, or in patients in a 
particular risk group (e.g., intensive care patients or patients using diuretics). 
In recent years, however, it has become clear that chronic and mild electrolyte 
disorders also are associated with adverse outcomes, including in the general 
population.1 Because of these emerging insights, it is important to know the exact 
prevalence and risk factors of electrolyte disorders in the general population. Mild 
electrolyte disorders are common in the general population aged 55 years or more 
(15%). Risk factors for electrolyte disorders in the general population are similar to 
those in hospitalized patients, including diabetes mellitus and all types of diuretics. 
 
2. OBJECTIVES: 
The aim of this study is to determine the incidence and risk factors of common 
electrolyte disorders in critically ill Egyptian people. 
 
3. METHODOLOGY:  
Patients and Methods: 
 Type of Study: A single-centre prospective cohort study 
 Study Setting and ethical consideration: The approval of the Scientific Research 

  
NCT06097104 
Date of Document 
26.9.2023 
Ethics Committee of the Faculty of Medicine, Ain Shams University will be 
obtained before starting work on the study. 
 Study Period: One year (2023-2024) 
 Study Population: critically ill Egyptian patients  
 Selection criteria for cases: 
o Inclusion Criteria:  
All patients admitted to medical ICU, surgical ICU and CCU suffering from 
electrolyte imbalance (EI) over 18 years with the comorbid conditions like 
(hypertension, heart failure, chronic chest diseases, cancer, chronic kidney disease, 
diabetes mellitus, cardiac dysrhythmias, pneumonia, sepsis, dehydration, and critical 
bones fractures, etc.)  
o 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 
 Ethical Considerations:  
1. Informed and written consent  
2. Patient information sheet  
3. Confidentiality  
4. Privacy  
5. Respect & responsibility 
 Sample Size: Using the PASS 15 program for sample size calculation, reviewing 
results from the previous relevant study (Ibrahim et al,2022  ) showed that the 
incidence of hypokalemia was 80.5%, with a margin  of error =10% and 95% 
confidence level and after a  10% adjustment for dropout rate a sample size of at 
least 110 patients will be needed. 
 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  

  
NCT06097104 
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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) 14 
A correction formula was also used to calculate albumin-corrected calcium 
levels (mmol/L)  
Corrected Calcium = (0.8 (Normal Albumin - Pt's Albumin)) + Serum Ca15 
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 Interventions:  
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 16. 
 Statistical package and Analysis:  
The collected data will be revised, coded and introduced to a PC using 
statistical package for social science (SPSS 15.0.1. for windows; SPSS Inc, Chicago, 
IL, 2001).  

  
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Data will be presented as mean and standard deviation (+- SD) for quantitative 
prometric data. Suitable analysis will be done according to the type of data obtained. 
P< 0.05 will be considered significant.  
 
4. REFERENCES:  
1. 
Giordano M, Ciarambino T, Castellino P, Malatino L, Di Somma S, Biolo 
G, et al. Diseases associated with electrolyte imbalance in the ED: age-related 
differences. Am J Emerg Med. 2016;34(10):1923–6.  
2. 
Lindner G, Pfortmuller CA, Leichtle AB, Fiedler GM, Exadaktylos 
AK. Age-related variety in electrolyte levels and prevalence of dysnatremias 
and dyskalemias in patients presenting to the emergency department. Gerontology. 
2014;60(5):420–3.  
3. 
Liamis G, Rodenburg EM, Hofman A, Zietse R, Stricker BH, Hoorn 
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Tentori F, Blayney MJ, Albert JM, Gillespie BW, Kerr PG, Bommer J, et 
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electrolytes disorder and its associated factors among adults admitted with 

  
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