Institutional Registry of Hyponatremia

This study is currently recruiting participants.
Verified March 2014 by Hospital Italiano de Buenos Aires
Sponsor:
Information provided by (Responsible Party):
Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier:
NCT01370473
First received: May 2, 2011
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition
Hyponatremia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Institutional Registry of Hyponatremia

Further study details as provided by Hospital Italiano de Buenos Aires:

Primary Outcome Measures:
  • clinical features [ Time Frame: feature clinics are evaluated during the acute episode and mortality were measured in the acute episode and in the semiannual monitoring by telephone ] [ Designated as safety issue: No ]
    Signs and symptoms Hospital Length of Stay Mortality Therapy


Estimated Enrollment: 2000
Study Start Date: December 2006
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults with hyponatremia

Criteria

Inclusion Criteria:

  1. Over 17 years.
  2. 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.
  3. First detection of sodium less than 130 mmol / l defined as exacerbation of chronic hyponatremia patients.
  4. Reepisodio defined as hyponatremia in patients who recovered the acute episode and again have a new episode of acute hyponatremia.

Exclusion Criteria:

  1. The refusal to register or to the informed consent process.
  2. Error in the measurement of sodium in the opinion of treating physician / recognized laboratory.
  3. Chronic renal patients on hemodialysis or peritoneal dialysis.
  4. Sodium determinations patients with cardiovascular surgery during cardiopulmonary bypass with intraoperative sodium determinations.
  5. Outpatients (excluding patients with PS on guard and spontaneous demand, see definitions).
  6. Patients treated (removal of blood and determination of serum sodium) in San Justo.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370473

Contacts
Contact: Diego H Giunta, MD 5411-9590200 ext 4419 diego.giunta@hospitalitaliano.org.ar

Locations
Argentina
HOspital Italiano de Buenos Aires Recruiting
Gascon 450, Buenos Aires, Argentina
Contact: Diego H Giunta, MD    541149590200 ext 4419    diego.giunta@hospitalitaliano.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
  More Information

No publications provided

Responsible Party: Diego Hernan Giunta, MD, MD, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01370473     History of Changes
Other Study ID Numbers: 1050
Study First Received: May 2, 2011
Last Updated: March 20, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Hospital Italiano de Buenos Aires:
Hyponatremia

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014