NCT06109532

Brief Summary

Prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and November 1, 2023. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
530

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 1, 2016

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

7.8 years

First QC Date

October 25, 2023

Last Update Submit

October 31, 2023

Conditions

Keywords

HYPONATREMIADENGUEINFLAMMATION

Outcome Measures

Primary Outcomes (1)

  • Admission to the hospital

    Risk for admission to the hospital

    between january 1, 2023 and november 1, 2023

Study Arms (3)

DENGUE INFECTED PATIENTS. YEAR 2016

We conducted a prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and december 31, 2016. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.

Other: hyponatremia

DENGUE INFECTED PATIENTS. YEAR 2020

We conducted a prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2020, and december 31, 2020. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.

Other: hyponatremia

DENGUE INFECTED PATIENTS. YEAR 2023

We conducted a prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2023, and november 1, 2023. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.

Other: hyponatremia

Interventions

hyponatremia at admission in dengue infected patients

DENGUE INFECTED PATIENTS. YEAR 2016DENGUE INFECTED PATIENTS. YEAR 2020DENGUE INFECTED PATIENTS. YEAR 2023

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and May 31, 2023.

You may qualify if:

  • Diagnosis confirmed by PCR, non structural protein 1 (NS1) antigen or IgM serology.
  • Plasma sodium at admission.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ladislao Diaz Ballve

Haedo, Buenos Aires, 1706, Argentina

RECRUITING

Hospital Posadas

Buenos Aires, 1684, Argentina

RECRUITING

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: 34926496BACKGROUND

MeSH Terms

Conditions

HyponatremiaDengueInflammation

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesMosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, ViralPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • CARLOS EGHI, MD

    HOSPITAL NACIONAL PROF. A. POSADAS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LADISLAO DIAZ BALLVE, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
8 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

January 1, 2016

Primary Completion

October 30, 2023

Study Completion

October 31, 2023

Last Updated

November 2, 2023

Record last verified: 2023-10

Locations