HYPONATREMIA IN COVID-19 PATIENTS | NCT04493268

Studies
HYPONATREMIA IN COVID-19 PATIENTS

NCT04493268

Sponsor

Hospital Nacional Profesor Alejandro Posadas

Status

Completed

Last Update Posted

Jul 30, 2020Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Hyponatremia
Covid19
Corona Virus Infection

Interventions

Not provided

Countries

Argentina

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 7, 2020Actual

Primary Completion Date

Jul 20, 2020Actual

Completion Date

Jul 21, 2020Actual

First Submitted Date

Jul 28, 2020

First Submission Date that Met QC Criteria

Jul 29, 2020

First Posted Date

Jul 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2020

Last Update Posted Date

Jul 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ladislao Diaz Ballve, GRADUATE IN KINESIOLOGY, Hospital Nacional Profesor Alejandro PosadasPrincipal Investigator

Lead Sponsor

Hospital Nacional Profesor Alejandro PosadasOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MORTALITY	HYPONATREMIA AND MORTALITY	30 DAYS

Secondary Outcomes

Measure	Description	Time Frame
ICU HOSPITALIZATION	HYPONATREMIA AND ICU HOSPITALIZATION	30 DAYS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

GENERAL POPULATION

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CARLOS EGHI, physician	University of Buenos Aires	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Posadas		Buenos Aires		1684	Argentina

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34926496	Derived	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.

ID	Term
D007010	Hyponatremia
D000086382	COVID-19
D018352	Coronavirus Infections
D007249	Inflammation

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D011024	Pneumonia, Viral