Electrolyte ImbalanceNCT04539834
Electrolyte State in Patients With COVID-19
An observational study of Electrolyte Imbalance, run by Zagazig University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Electrolyte Imbalance
- What is being tested?
- electrolytes
- How many people
- 983 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 30 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients ≥ 18 years old who were confirmed by the real-time PCR on the respiratory tract samples as positive of SARS-CoV-2.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Electrolyte Imbalance
- Being tested
- electrolytes
- Keywords
- Electrolytes; COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrolytesOther
measuring level of electrolytes
What is being measured
The primary outcome is the main question the study is designed to answer.
electrolytes disturbances in patients with COVID-19
Serum Electrolytes (Na, K, Ca, Cl, Ph, Mg) abnormality in COVID 19 patients laboratory results in the different stages of the disease
Measured: 4 months
Secondary outcomes (1)
To asses the relation of the electrolyte disturbances with the severity of COVID-19 infection.
To find any correlation between the level of the electrolyte disturbances and the morbidity and mortality of the disease .
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 May 2020
- Primary completion1 Aug 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrolyte ImbalanceStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 983 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Essamedin Mamdouh Negm, Zagazig University
- Investigators
- Tarek Hamdy, MD, Study director, lecturer of Chest diseases, Faculty of Medicine, Zagazig UniversityHadeer El Shahaat, master degree, Principal investigator, Assistant lecturer of Chest diseases, Faculty of Medicine, Zagazig UniversityAhmed Abdulsaboor, MD, Principal investigator, Clinical Pathology Department, Faculty of Medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539834
- Sponsor's protocol ID
- (ZU-IRB#: 6328-23-8-2020)
- Status last verified
- Nov 2021
- First submitted
- 1 Sep 2020
- Last updated
- 23 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrolyte State in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04539834
- Acronym / sponsor ID
- (ZU-IRB#: 6328-23-8-2020)
- Conditions
- Electrolyte Imbalance
- Keywords
- Electrolytes; COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 983 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients ≥ 18 years old who were confirmed by the real-time PCR on the respiratory tract samples as positive of SARS-CoV-2.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrolytesmeasuring level of electrolytes | Other | – |
Primary outcome
electrolytes disturbances in patients with COVID-19
Time frame: 4 months
Serum Electrolytes (Na, K, Ca, Cl, Ph, Mg) abnormality in COVID 19 patients laboratory results in the different stages of the disease
1 secondary outcome
To asses the relation of the electrolyte disturbances with the severity of COVID-19 infection.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Hamdy, MD study director
lecturer of Chest diseases, Faculty of Medicine, Zagazig University
Hadeer El Shahaat, master degree principal investigator
Assistant lecturer of Chest diseases, Faculty of Medicine, Zagazig University
Ahmed Abdulsaboor, MD principal investigator
Clinical Pathology Department, Faculty of Medicine, Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrolyte Imbalance, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electrolytes disturbances in patients with COVID-19 (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.