Electrolyte State in Patients With COVID-19

Completed

• Conditions: Electrolyte Imbalance

• Registration Number: NCT04539834
• Lead Sponsor: Zagazig University

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

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-07
• Primary Completion: 2021-08-01
• Study Completion: 2021-10-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-20
• Last Update Posted: 2021-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 983

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
electrolytes disturbances in patients with COVID-19	4 months	Serum Electrolytes (Na, K, Ca, Cl, Ph, Mg) abnormality in COVID 19 patients laboratory results in the different stages of the disease

Secondary Outcome Measures

Name	Time	Method
To asses the relation of the electrolyte disturbances with the severity of COVID-19 infection.	4 months	To find any correlation between the level of the electrolyte disturbances and the morbidity and mortality of the disease .

Trial Locations

Locations (1)

Zagazig University; 🇪🇬 Zagazig, Egypt