HyponatremiaNCT04493268
HYPONATREMIA IN COVID-19 PATIENTS
An observational study of Hyponatremia and Covid19, run by Hospital Nacional Profesor Alejandro Posadas at 1 site in Argentina.
Trial summary
SYSTEMIC INFLAMMATION HAS BEEN ASSOCIATED WITH SEVERE COVID-19. HYPONATREMIA CAN RESULT FROM INFLAMMATION DUE TO NON-OSMOTIC STIMULI FOR VASOPRESSIN PRODUCTION. IN THIS PROSPECTIVE COHORT STUDY WE ANALIZED DATA FROM PATIENTS WITH COVID-19 AND THE ASOCIATION WITH HYPONATREMIA AND CLINICAL OUTCOMES. Read more about this study
- Who is it for?
- Ages 1 month to 100 years
- Conditions the study is for
- Hyponatremia, Covid19, Corona Virus Infection
- How many people
- 250 participants
- Where
- 1 siteArgentina
- Study dates
- 7 Mar 2020to 21 Jul 2020
- 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 1 month to 100 years
- All sexes
- Child, Adult, Older adult
Study population: GENERAL POPULATION
Who may be able to join
- PATIENTS WITH SARS-CoV-2 INFECTION CONFIRMED BY PCR OF NASOPHARYNGEAL SWABS.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HYPONATREMIA AND INFLAMMATION AND CLINICAL OUTCOMES IN HOSPITALIZED COVID-19 PATIENTS
SYSTEMIC INFLAMMATION HAS BEEN ASSOCIATED WITH SEVERE COVID-19. HYPONATREMIA CAN RESULT FROM INFLAMMATION DUE TO NON-OSMOTIC STIMULI FOR VASOPRESSIN PRODUCTION. IN THIS PROSPECTIVE COHORT STUDY WE ANALIZED DATA FROM PATIENTS WITH COVID-19 AND THE ASOCIATION WITH HYPONATREMIA AND CLINICAL OUTCOMES.
- Conditions
- Hyponatremia, Covid19, Corona Virus Infection
- Keywords
- INFLAMMATION, COVID, CORONA
- Medical subject headings
- Hyponatremia, COVID-19, Coronavirus Infections, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
MORTALITY
HYPONATREMIA AND MORTALITY
Measured: 30 DAYS
Secondary outcomes (1)
ICU HOSPITALIZATION
HYPONATREMIA AND ICU HOSPITALIZATION
Measured: 30 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start7 Mar 2020
- Primary completion20 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nacional Profesor Alejandro Posadas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ladislao Diaz Ballve, Hospital Nacional Profesor Alejandro Posadas
- Investigators
- CARLOS EGHI, physician, Principal investigator, University of Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493268
- Sponsor's protocol ID
- HYPONATREMIA IN COVID PATIENTS
- Status last verified
- Jul 2020
- First submitted
- 28 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ayus JC, Negri AL, Moritz ML, Lee KM, Caputo D, Borda ME, Go AS, Eghi C. Hyponatremia, Inflammation at Admission, and Mortality in Hospitalized COVID-19 Patients: A Prospective Cohort Study. Front Med (Lausanne). 2021 Dec 2;8:748364. doi: 10.3389/fmed.2021.748364. eCollection 2021.
PubMed 34926496
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPONATREMIA AND INFLAMMATION AND CLINICAL OUTCOMES IN HOSPITALIZED COVID-19 PATIENTS
- ClinicalTrials.gov ID
- NCT04493268
- Acronym / sponsor ID
- HYPONATREMIA IN COVID PATIENTS
- Conditions
- Hyponatremia, Covid19, Corona Virus Infection
- Keywords
- INFLAMMATION, COVID, CORONA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hospital Nacional Profesor Alejandro PosadasUniversity, hospital or other
- Study start
- 7 Mar 2020 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 30 Jul 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.
SYSTEMIC INFLAMMATION HAS BEEN ASSOCIATED WITH SEVERE COVID-19. HYPONATREMIA CAN RESULT FROM INFLAMMATION DUE TO NON-OSMOTIC STIMULI FOR VASOPRESSIN PRODUCTION. IN THIS PROSPECTIVE COHORT STUDY WE ANALIZED DATA FROM PATIENTS WITH COVID-19 AND THE ASOCIATION WITH HYPONATREMIA AND CLINICAL OUTCOMES.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- GENERAL POPULATION
Key inclusion criteria (1 listed)
- PATIENTS WITH SARS-CoV-2 INFECTION CONFIRMED BY PCR OF NASOPHARYNGEAL SWABS.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MORTALITY
Time frame: 30 DAYS
HYPONATREMIA AND MORTALITY
1 secondary outcome
ICU HOSPITALIZATION
Time frame: 30 DAYS
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 30 Jul 2020.
- Derived from this study: PubMed 34926496Ayus JC, Negri AL, Moritz ML, Lee KM, Caputo D, Borda ME, Go AS, Eghi C. Hyponatremia, Inflammation at Admission, and Mortality in Hospitalized COVID-19 Patients: A Prospective Cohort Study. Front Med (Lausanne). 2021 Dec 2;8:748364. doi: 10.3389/fmed.2021.748364. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
CARLOS EGHI, physician principal investigator
University of Buenos Aires
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 Hyponatremia and Covid19, run by Hospital Nacional Profesor Alejandro Posadas at 1 site in Argentina.
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: finished, as of the sponsor's last update on 30 Jul 2020. 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 Argentina. 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?
MORTALITY (time frame: 30 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04493268, which also lists 1 linked publication.
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 30 Jul 2020.