NCT01370473

Brief Summary

The purpose of this study is to create an institutional and population-based registry of Hyponatremia with a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival. This study will also describe the occurrence of hyponatremia in the population of HIBA in the Central Hospital, as well as the characteristics of clinical presentation, evolution and predisposing factors of hyponatremia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2006

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

7.4 years

First QC Date

May 2, 2011

Last Update Submit

August 9, 2019

Conditions

Keywords

Hyponatremia

Outcome Measures

Primary Outcomes (1)

  • clinical features

    Signs and symptoms Hospital Length of Stay Mortality Therapy

    feature clinics are evaluated during the acute episode and mortality were measured in the acute episode and in the semiannual monitoring by telephone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with hyponatremia

You may qualify if:

  • Over 17 years.
  • At least a measure of central laboratory Na less than 130 mmol / l in patients without criteria for chronic hyponatremia or at least a measure of central laboratory Na greater than or equal to 150 mmol / l.
  • First detection of sodium less than 130 mmol / l defined as exacerbation of chronic hyponatremia patients.
  • Reepisodio defined as hyponatremia in patients who recovered the acute episode and again have a new episode of acute hyponatremia.

You may not qualify if:

  • The refusal to register or to the informed consent process.
  • Error in the measurement of sodium in the opinion of treating physician / recognized laboratory.
  • Chronic renal patients on hemodialysis or peritoneal dialysis.
  • Sodium determinations patients with cardiovascular surgery during cardiopulmonary bypass with intraoperative sodium determinations.
  • Outpatients (excluding patients with PS on guard and spontaneous demand, see definitions).
  • Patients treated (removal of blood and determination of serum sodium) in San Justo.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, 1199, Argentina

Location

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Diego H Giunta, MD

    Hospital Italiano de Buenos Aires

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 2, 2011

First Posted

June 10, 2011

Study Start

December 1, 2006

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations