- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04539834
Electrolyte State in Patients With COVID-19
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.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Zagazig, Egypt, 055
- Zagazig University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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electrolytes disturbances in patients with COVID-19
Time Frame: 4 months
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Serum Electrolytes (Na, K, Ca, Cl, Ph, Mg) abnormality in COVID 19 patients laboratory results in the different stages of the disease
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4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To asses the relation of the electrolyte disturbances with the severity of COVID-19 infection.
Time Frame: 4 months
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To find any correlation between the level of the electrolyte disturbances and the morbidity and mortality of the disease .
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4 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tarek Hamdy, MD, lecturer of Chest diseases, Faculty of Medicine, Zagazig University
- Principal Investigator: Hadeer El Shahaat, master degree, Assistant lecturer of Chest diseases, Faculty of Medicine, Zagazig University
- Principal Investigator: Ahmed Abdulsaboor, MD, Clinical Pathology Department, Faculty of Medicine, Zagazig University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- (ZU-IRB#: 6328-23-8-2020)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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