NCT04493268

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

July 28, 2020

Last Update Submit

July 29, 2020

Conditions

HyponatremiaCovid19Corona Virus Infection

Keywords

INFLAMMATIONCOVIDCORONA

Outcome Measures

Primary Outcomes (1)

  • MORTALITY

    HYPONATREMIA AND MORTALITY

    30 DAYS

Secondary Outcomes (1)

  • ICU HOSPITALIZATION

    30 DAYS

Eligibility Criteria

Age1 Month - 100 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

GENERAL POPULATION

You may qualify if:

  • PATIENTS WITH SARS-CoV-2 INFECTION CONFIRMED BY PCR OF NASOPHARYNGEAL SWABS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Posadas

Buenos Aires, 1684, Argentina

Location

Related Publications (1)

  • 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.

    PMID: 34926496DERIVED

MeSH Terms

Conditions

HyponatremiaCOVID-19Coronavirus InfectionsInflammation

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • CARLOS EGHI, physician

    University of Buenos Aires

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
GRADUATE IN KINESIOLOGY

Study Record Dates

First Submitted

July 28, 2020

First Posted

July 30, 2020

Study Start

March 7, 2020

Primary Completion

July 20, 2020

Study Completion

July 21, 2020

Last Updated

July 30, 2020

Record last verified: 2020-07

Locations

AR(1)