COVID-19NCT05408481
Relation Between COVID-19 Pts and Hyponatremia in Adreno Ortical Insufficient Patients.
An observational study of COVID-19, run by Assiut University.
Trial summary
Hyponatremia in COVID-19 patients with adrenal insufficiency Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Serum cortisol level
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Mar 2023
- 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 19 to 80 years
- All sexes
- Adult, Older adult
Study population: COVID-19 patients
Who may be able to join
- 1-Suspected COVID-19 patients come to isolation hospital in Assuit. 2-Hyponatremia. 3- Adrenal insufficiency
Who cannot join
- Non-cooperative patients
About this study
Official title: Hyponatremia in COVID-19 Patients With Adrenal Insufficiency and Its Relation to Mortality and Survival Scores.
Hyponatremia in COVID-19 patients with adrenal insufficiency
Read the detailed description
Hyponatremia is the most prevalent hydroelectrolytic disorder in clinical practice, and is linked to higher rates of morbidity and mortality. 1, 2.Sodium balance disorder, particularly hyponatremia, is a common condition among hospitalized patients with COVID-19 . and it is associated with a higher risk of morbidity, mortality, and disability. Acute hyponatremia causes serious brain swelling that can lead to permanent disability or death. Chronic hyponatremia causes attention deficit, gait instability, and osteoporosis, Mechanisms of hyponatremia in coronavirus disease 2019 (COVID-19) patients. Osmotic syndrome of inappropriate antidiuretic hormone release (SIADH) as a major mechanism. Also hypovolemic hyponatremia that may have been common in COVID-19 patients since nausea, vomiting, diarrhea.we predict critical illness-related corticosteroid insufficiency (CIRCI) play a role in hyponatremia in COVID-19 , high percentage of critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection in the study were treated with vasopressors (2). Angiotensin-converting enzyme 2 receptor and transmembrane serine protease 2 serine protease were colocalized in adrenocortical cells in the zona fasciculata and zona reticularis (2). plasma cortisol concentrations will be collected in critically ill patients with COVID-19 (2). The cortisol levels of critically ill patients with COVID-19 were low(2).We aimed to identify the previlence and mortality rate of hyponatremia in covid 19 patient with adrenal insufficiency . Our studies will present in Assiut hospital university on patients in isolation ward from October 2021 to October 2022.
- Conditions
- COVID-19
- Being tested
- Serum cortisol level
- Keywords
- Hyponatremia
- Medical subject headings
- COVID-19, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum cortisol levelDiagnostic test
Biochemical test
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of hyponatremia on mortality of COVID-19 patient with adrenal insufficiency
Na level will be measured in COVID-19 patients with adrenal insufficiency
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Mostafa Abdel Raheem Gad El Rab, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408481
- Sponsor's protocol ID
- COVID-19 hyponatremia
- Status last verified
- Jun 2022
- First submitted
- 4 Jun 2022
- Last updated
- 7 Jun 2022
- 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 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyponatremia in COVID-19 Patients With Adrenal Insufficiency and Its Relation to Mortality and Survival Scores.
- ClinicalTrials.gov ID
- NCT05408481
- Acronym / sponsor ID
- COVID-19 hyponatremia
- Conditions
- COVID-19
- Keywords
- Hyponatremia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 7 Jun 2022 (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.
Hyponatremia in COVID-19 patients with adrenal insufficiency
Detailed description
Hyponatremia is the most prevalent hydroelectrolytic disorder in clinical practice, and is linked to higher rates of morbidity and mortality. 1, 2.Sodium balance disorder, particularly hyponatremia, is a common condition among hospitalized patients with COVID-19 . and it is associated with a higher risk of morbidity, mortality, and disability. Acute hyponatremia causes serious brain swelling that can lead to permanent disability or death. Chronic hyponatremia causes attention deficit, gait instability, and osteoporosis, Mechanisms of hyponatremia in coronavirus disease 2019 (COVID-19) patients. Osmotic syndrome of inappropriate antidiuretic hormone release (SIADH) as a major mechanism. Also hypovolemic hyponatremia that may have been common in COVID-19 patients since nausea, vomiting, diarrhea.we predict critical illness-related corticosteroid insufficiency (CIRCI) play a role in hyponatremia in COVID-19 , high percentage of critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection in the study were treated with vasopressors (2). Angiotensin-converting enzyme 2 receptor and transmembrane serine protease 2 serine protease were colocalized in adrenocortical cells in the zona fasciculata and zona reticularis (2). plasma cortisol concentrations will be collected in critically ill patients with COVID-19 (2). The cortisol levels of critically ill patients with COVID-19 were low(2).We aimed to identify the previlence and mortality rate of hyponatremia in covid 19 patient with adrenal insufficiency . Our studies will present in Assiut hospital university on patients in isolation ward from October 2021 to October 2022.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patients
Key inclusion criteria (1 listed)
- 1-Suspected COVID-19 patients come to isolation hospital in Assuit. 2-Hyponatremia. 3- Adrenal insufficiency
Key exclusion criteria (1 listed)
- Non-cooperative patients
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 |
|---|---|---|
| Serum cortisol levelBiochemical test | Diagnostic test | – |
Primary outcome
The effect of hyponatremia on mortality of COVID-19 patient with adrenal insufficiency
Time frame: Baseline
Na level will be measured in COVID-19 patients with adrenal insufficiency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The effect of hyponatremia on mortality of COVID-19 patient with adrenal insufficiency (time frame: Baseline). 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 7 Jun 2022.