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RecruitingNCT06109532HINDIPUpdated Nov 2, 2023

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

An observational study in Hyponatremia, Dengue and Inflammation, sponsored by Hospital Nacional Profesor Alejandro Posadas. Recruiting at 2 sites in Argentina. Per ClinicalTrials.gov, last updated 2023-11-02.

Sponsored by Hospital Nacional Profesor Alejandro Posadas · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as recruiting.
  • Started Jan 2016; still recruiting 10 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
530
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyponatremia
  • Dengue
  • Inflammation

Keywords

  • HYPONATREMIA
  • DENGUE
  • INFLAMMATION
03

In context

Hyponatremia

164 studies on the registry are indexed under Hyponatremia; 16 are open to participants now.

This study's planned enrollment of 530 is above the median of 200 across 61 observational studies indexed under Hyponatremia.

Browse Hyponatremia studies →

Lead sponsor

Hospital Nacional Profesor Alejandro Posadas is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Plasma sodium at admission.

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
530 participants (estimated)
Target follow-up
8 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • Otherhyponatremia

    hyponatremia at admission in dengue infected patients

06

What researchers measure

Primary outcomes

  1. Admission to the hospital

    Risk for admission to the hospital

    Time frame: between january 1, 2023 and november 1, 2023

07

Study locations

2 of 2 sites recruiting
  • Ladislao Diaz Ballve
    Haedo, Buenos Aires 1706, Argentina
    Recruiting
  • Hospital Posadas
    Buenos Aires, 1684, Argentina
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2016 (actual). Primary completion is estimated for Oct 2023, 93 months after the start.

Of 18 observational studies under Hyponatremia, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 59. This study's planned 93 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2023
First posted
Oct 31, 2023
StartActual
Jan 1, 2016
Primary completionEst.
Oct 30, 2023
CompletionEst.
Oct 31, 2023
Last update
Nov 2, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06109532
Lead sponsor
Hospital Nacional Profesor Alejandro Posadas
Responsible party
Ladislao Diaz Ballve (Principal Investigator, Hospital Nacional Profesor Alejandro Posadas) — Principal investigator
First posted
Oct 31, 2023
Start date
Jan 1, 2016
Primary completion
Oct 30, 2023 (estimated)
Completion
Oct 31, 2023 (estimated)
Last update
Nov 2, 2023

Study contacts

CARLOS EGHI, MD
Contact
carlisluyemm@hotmail.com
+541166939309
LADISLAO DIAZ BALLVE, PHD
Contact
ladislaodiaz@gmail.com
CARLOS EGHI, MD
principal investigator · HOSPITAL NACIONAL PROF. A. POSADAS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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