HyponatremiaHINDIPNCT06109532
Prevalence of Hyponatremia in Dengue Infected Patients: Relationship With Systemic Inflammation.
An observational study of Hyponatremia and Dengue, run by Hospital Nacional Profesor Alejandro Posadas at 2 sites in Argentina.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyponatremia, Dengue, Inflammation
- What is being tested?
- hyponatremia
- How many people
- 530 participants
- Where
- 2 sitesArgentina
- Study dates
- 1 Jan 2016to 31 Oct 2023
- How long will I take part?
- 8 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and May 31, 2023.
Who may be able to join
- Diagnosis confirmed by PCR, non structural protein 1 (NS1) antigen or IgM serology.
- Plasma sodium at admission.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
LADISLAO DIAZ BALLVE, PHD contact
Argentina2 sites, 2 recruiting
- Recruiting
Hospital Posadas
Buenos Aires, 1684
CARLOS EGHI, PHYSICIAN, +541166939309, carlisluyemm@hotmail.com
- Recruiting
Ladislao Diaz Ballve
Haedo, Buenos Aires, 1706
Ladislao P Diaz-Ballve, Lic., +54(011)67887437, ladislaodiaz@gmail.com
About this study
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.
- Conditions
- Hyponatremia, Dengue, Inflammation
- Being tested
- hyponatremia
- Keywords
- HYPONATREMIA, DENGUE, INFLAMMATION
- Medical subject headings
- Hyponatremia, Dengue, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyponatremiaOther
hyponatremia at admission in dengue infected patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: hyponatremia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission to the hospital
Risk for admission to the hospital
Measured: between january 1, 2023 and november 1, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Jan 2016
- Primary completion30 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 530 participants (estimated)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- Hospital Nacional Profesor Alejandro Posadas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ladislao Diaz Ballve, Hospital Nacional Profesor Alejandro Posadas
- Investigators
- CARLOS EGHI, MD, Principal investigator, HOSPITAL NACIONAL PROF. A. POSADAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109532
- Sponsor's protocol ID
- HINDIP162023
- Acronym
- HINDIP
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hyponatremia in Dengue Infected Patients: Relationship With Systemic Inflammation.
- ClinicalTrials.gov ID
- NCT06109532
- Acronym / sponsor ID
- HINDIP / HINDIP162023
- Conditions
- Hyponatremia, Dengue, Inflammation
- Keywords
- HYPONATREMIA, DENGUE, INFLAMMATION
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- Hospital Nacional Profesor Alejandro PosadasUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DENGUE INFECTED PATIENTS. YEAR 2016 | – | Other: hyponatremiaWe 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. |
| DENGUE INFECTED PATIENTS. YEAR 2020 | – | Other: hyponatremiaWe 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. |
| DENGUE INFECTED PATIENTS. YEAR 2023 | – | Other: hyponatremiaWe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and May 31, 2023.
Key inclusion criteria (2 listed)
- Diagnosis confirmed by PCR, non structural protein 1 (NS1) antigen or IgM serology.
- Plasma sodium at admission.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyponatremiahyponatremia at admission in dengue infected patients | Other | DENGUE INFECTED PATIENTS. YEAR 2016, DENGUE INFECTED PATIENTS. YEAR 2020, DENGUE INFECTED PATIENTS. YEAR 2023 |
Primary outcome
Admission to the hospital
Time frame: between january 1, 2023 and november 1, 2023
Risk for admission to the hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Background: PubMed 34926496Ayus 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.
- Individual participant dataSharing planned: Undecided
Related trials for Hyponatremia
RecruitingPhase 3
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
Hyponatremia, Osmotic Demyelination Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LADISLAO DIAZ BALLVE, PHD contact
CARLOS EGHI, MD principal investigator
HOSPITAL NACIONAL PROF. A. POSADAS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia and Dengue, run by Hospital Nacional Profesor Alejandro Posadas at 2 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CARLOS EGHI, MD (+541166939309, carlisluyemm@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission to the hospital (time frame: between january 1, 2023 and november 1, 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06109532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2023.