Clinical trial NCT04539834: Electrolyte State in Patients With COVID-19
Official title: Electrolyte State in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electrolyte Imbalance
Keywords: Electrolytes; COVID-19
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-09-07
Enrollment: 983
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients ≥ 18 years old with diagnosis of COVID-19 infection who admitted to Isolation hospital of Zagazig University Hospitals during the period from 1 May 2020 to 1 August 2020.

Brief summary: Initial case reports and cohort studies have described many clinical characteristics of patients with coronavirus disease 2019 (COVID-19), an emerging infectious disorder caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In early COVID-19 studies, some evidence has been provided that electrolyte disorders may also be present upon patients' presentation, including sodium, potassium, chloride and calcium abnormalities

the aim of the study is Identification of elements that affect COVID-19 pathology to improve survival and decrease mortality rate.

Detailed description: SARS-CoV-2 invades human cells through binding angiotensin I converting enzyme 2 (ACE2) on the cell membrane. ACE2 is widely distributed in many types of human tissues, especially in the vital organs, such as heart, liver, kidney, and lungs. ACE2 is viewed as the principal counter-regulatory mechanism for the main axis of renin-angiotensin system (RAS) that is an essential player in the control of blood pressure and electrolyte balance. The final effect is to increase reabsorption of sodium and water, and thereafter increase blood pressure and excretion of potassium (K+). Besides, patients with COVID-19 often had gastrointestinal symptoms such as diarrhea and vomiting

Early studies proved that high percentage of COVID-19 patient were presented with electrolyte disorders, including sodium, potassium, chloride and calcium abnormalities. Such electrolyte disturbances have important implications not only for patient management but also for identifying potential pathophysiologic mechanisms underlying COVID-19 that could drive novel therapeutic opportunities

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old who were confirmed by the real-time PCR on the respiratory tract samples as positive of SARS-CoV-2.

Exclusion Criteria:

* Patients who had other causes of electrolyte disturbances (9):
* Chronic organ dysfunction (e.g., hepatic or renal dysfunction),
* Terminal cancer, immunodeficiency, and
* Patients with a history of long-term use of hormones \& Diuretics were excluded.

Primary outcomes:
measure: electrolytes disturbances in patients with COVID-19
timeFrame: 4 months
Secondary outcomes:
measure: To asses the relation of the electrolyte disturbances with the severity of COVID-19 infection.
timeFrame: 4 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University
Study officials:
affiliation: lecturer of Chest diseases, Faculty of Medicine, Zagazig University
name: Tarek Hamdy, MD
role: STUDY_DIRECTOR
affiliation: Assistant lecturer of Chest diseases, Faculty of Medicine, Zagazig University
name: Hadeer El Shahaat, master degree
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Pathology Department, Faculty of Medicine, Zagazig University
name: Ahmed Abdulsaboor, MD
role: PRINCIPAL_INVESTIGATOR
References: