HINDIP: Prevalence of Hyponatremia in Dengue Infected Patients: Relationship With Systemic Inflammation.

Sponsor

Hospital Nacional Profesor Alejandro Posadas (Other)

Overall Status

Recruiting

CT.gov ID

NCT06109532

Collaborator

(none)

530

Enrollment

Locations

Anticipated Duration (Months)

265

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyponatremia Dengue Inflammation	Other: hyponatremia

Detailed Description

Background Dengue infection is becoming more prevalent worldwide and is associated with systemic inflammation. Systemic Inflammation is associated with non-osmotic release of ADH.

Methods: Participants conducted a 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

530 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prevalence of Hyponatremia in Dengue Infected Patients: Relationship With Systemic Inflammation.

Actual Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 hyponatremia at admission in dengue infected patients
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 hyponatremia at admission in dengue infected patients
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 hyponatremia at admission in dengue infected patients

Arm

Intervention/Treatment

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

hyponatremia at admission in dengue infected patients

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

hyponatremia at admission in dengue infected patients

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

hyponatremia at admission in dengue infected patients

Outcome Measures

Primary Outcome Measures

Admission to the hospital [between january 1, 2023 and november 1, 2023]
Risk for admission to the hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis confirmed by PCR, non structural protein 1 (NS1) antigen or IgM serology.

Plasma sodium at admission.

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ladislao Diaz Ballve	Haedo	Buenos Aires	Argentina	1706
2	Hospital Posadas	Buenos Aires		Argentina	1684

Sponsors and Collaborators

Hospital Nacional Profesor Alejandro Posadas

Investigators

Principal Investigator: CARLOS EGHI, MD, HOSPITAL NACIONAL PROF. A. POSADAS

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Ladislao Diaz Ballve, Principal Investigator, Hospital Nacional Profesor Alejandro Posadas

ClinicalTrials.gov Identifier:

NCT06109532

Other Study ID Numbers:

HINDIP162023

First Posted:

Oct 31, 2023

Last Update Posted:

Nov 2, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ladislao Diaz Ballve, Principal Investigator, Hospital Nacional Profesor Alejandro Posadas

HYPONATREMIA

DENGUE

INFLAMMATION

Additional relevant MeSH terms:

Dengue

Hyponatremia

Inflammation

Study Results

No Results Posted as of Nov 2, 2023