Institutional Registry of Hyponatremia
Recruitment status was Recruiting
|First Received Date ICMJE||May 2, 2011|
|Last Updated Date||June 9, 2011|
|Start Date ICMJE||December 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01370473 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Institutional Registry of Hyponatremia|
|Official Title ICMJE||Institutional Registry of Hyponatremia|
The purpose of this study is to create a population-based registry system Hyponatremia prospective epidemiological survey of
risk factors, diagnosis, prognosis, treatment, monitoring, survival. This study will also describe the occurrence of hyponatremia in the population of HIBA in the Central Hospital, as well as describe the characteristics of clinical presentation, evolution and predisposing factors of hyponatremia.
Alterations in plasma sodium concentration (sodium ratio and solvent) are very common in clinical practice. Because the plasma sodium concentration is a major determinant of plasma osmolality, determined by both the balance of the different compartments of body fluids .
Hyponatremia is defined as the measurement of plasma sodium below 136 mmol per liter. Hyponatremia may be associated with normal tone, low or high . The pseudohiponatremia is an artifact of measuring the concentration of sodium in the context of an increase in the concentration of active osmoles (glucose, mannitol), which induce water movement from the intracellular to extracellular this can also occur in the context of substances that do not generate osmolarity as triglycerides and plasma proteins. In the first case the investigators are in the presence of hypertonic hyponatremia in the second case to an isotonic hyponatremia, neither should be considered true hyponatremia.
The hypotonic hyponatremia is true, represents the most common electrolyte imbalance in hospitalized patients (2% to 22% depending on the series and the cutoff points) and outpatients (7% to 18% in tertiary care center, being very dependent variable and cutoffs series) [1, 4-6]. Is associated with increased morbidity and mortality (18% in hospitalized patients) [7, 8]. You can be the cause of serious illness that requires immediate attention or be a marker of morbidity and mortality from underlying disease (congestive heart failure, liver cirrhosis) .
Hyponatremia can occur in a wide gamma of patients, from asymptomatic with good tolerance to the critically ill seriously. Symptoms may be mild or severe, and none is specific . They are mainly neurological and generally reflect dysfunction associated with cerebral edema. Is due both to the magnitude of the alteration of plasma sodium concentration and the speed of your system [9-11].
The clinical management challenge is the identification and specific treatment of the cause, understanding that the study of it brings the knowledge of its pathophysiology. The latter can be grouped into a loss of sodium and / or gain of fluid. In turn, the gain of liquids is possible by an alteration in kidney dilusorios mechanisms, as well as the variations that according to the glomerular filtration rate and filtered sodium load. Its high prevalence and potential neurologic sequelae associated with the disease and its treatment make the diagnosis and appropriate treatment is mandatory [6, 12, 13]. Traditionally, the initial assessment and treatment are suboptimal in the descriptive series .
The investigators did not find in the literature no systematic record of patients with abnormalities in the sodium concentration in both inpatient and outpatient, except a record of pharmacological effects . The investigators believe that while this is a highly prevalent disorder, is not attractive to the pharmaceutical industry and this would partly explain the apparent lack of studies with large groups of patients.
The investigators also found no descriptive studies conducted in Argentina. While there are multiple proposals for the evaluation of alterations in sodium, there is no standardization in our single on the cleavage of specific sodium, appropriate diagnostic evaluation and proposed the best treatment for hyponatremia. There are technical difficulties in the standardization of the assessment of symptoms, physical examination, and the effectiveness of clinical parameters to guide therapy [4, 5, 8, 15-18].
There are no reports of the strategy used in our country for diagnosis and decision making in patients with alterations of plasma sodium concentrations. Nor are there Disnatremias epidemiological data in our environment, risk factors, assessment and monitoring of survival, complications and recurrences. The investigators have no references in the literature that talk about the behavior of the disnatremias in the areas of inpatient and outpatient, there are no data to see whether treatments aimed at the mere correction of hyponatremia, or interpretation of the pathophysiological same.
The systematic recording of cases of Disnatremias will reveal the characteristics of the disease in our environment, the diagnostic strategies used and their results and the time course of the disease. The investigators believe that this knowledge will allow us to design studies to optimize and standardize the diagnostic strategies, evaluation and treatment, resulting in benefits for the affected population
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
Adults with hyponatremia
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||2000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||Argentina|
|NCT Number ICMJE||NCT01370473|
|Other Study ID Numbers ICMJE||1050|
|Has Data Monitoring Committee||No|
|Responsible Party||Diego Giunta, Hospital Italiano de Buenos Aires|
|Study Sponsor ICMJE||Hospital Italiano de Buenos Aires|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||Hospital Italiano de Buenos Aires|
|Verification Date||November 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP