Electrolyte State in Patients With COVID-19

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT04539834
Collaborator
(none)
983
1
18
54.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: electrolytes

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 Design

Study Type:
Observational
Actual Enrollment :
983 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Electrolyte State in Patients With COVID-19
Actual Study Start Date :
May 1, 2020
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
Oct 30, 2021

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zagazig University Zagazig Egypt 055

Sponsors and Collaborators

  • Zagazig University

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Essamedin Mamdouh Negm, lecturer, Zagazig University
ClinicalTrials.gov Identifier:
NCT04539834
Other Study ID Numbers:
  • (ZU-IRB#: 6328-23-8-2020)
First Posted:
Sep 7, 2020
Last Update Posted:
Nov 23, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Essamedin Mamdouh Negm, lecturer, Zagazig University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2021