HyponatremiaHyponatremiaNCT01370473
Institutional Registry of Hyponatremia
An observational study of Hyponatremia, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia
- How many people
- 2,000 participants
- Where
- 1 siteArgentina
- Study dates
- Dec 2006to May 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with hyponatremia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Alterations in plasma sodium concentration (sodium ratio and solvent) are very common in clinical practice. Since plasma sodium concentration is a major determinant of plasma osmolality, it will determine the balance of the different body fluids compartments.
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 pseudohyponatremia is an artifact of measuring the concentration of sodium in the context of a growth 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 hyponatremias.
The hypotonic hyponatremia is the one considered to be true. It 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). It is associated with increased morbidity and mortality (18% in hospitalized patients). It can be the cause of serious illness that requires immediate attention or be a marker of morbidity and mortality for underlying diseases (congestive heart failure, liver cirrhosis).
Hyponatremia can occur in a wide range of patients, from asymptomatic with good tolerance to the critically ill. Symptoms may be mild or severe, and none is specific. They are mainly neurological and generally reflect dysfunction associated with cerebral edema. They are caused due to the magnitude of the alteration of plasma sodium concentration and the system speed.
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. Traditionally, the initial assessment and treatment are suboptimal in the descriptive series.
We have not found in the literature any systematic record of patients with abnormalities in the sodium concentration in both inpatients and outpatients, except for a record of pharmacological effects. We 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.
We also have not found any 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.
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 Disnatremias epidemiological data in our environment, risk factors, assessment and monitoring of survival, complications and recurrences. We have no references in the literature that talk about the behaviour 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. We believe that this knowledge will allow us to design studies to optimize and standardize the diagnostic strategies, evaluation and treatment, resulting in a benefit for the affected population.
- Conditions
- Hyponatremia
- Keywords
- Hyponatremia
- Medical subject headings
- Hyponatremia
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical features
Signs and symptoms Hospital Length of Stay Mortality Therapy
Measured: feature clinics are evaluated during the acute episode and mortality were measured in the acute episode and in the semiannual monitoring by telephone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startDec 2006
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
- Investigators
- Diego H Giunta, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370473
- Sponsor's protocol ID
- 1050
- Acronym
- Hyponatremia
- Status last verified
- Aug 2019
- First submitted
- 2 May 2011
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institutional Registry of Hyponatremia
- ClinicalTrials.gov ID
- NCT01370473
- Acronym / sponsor ID
- Hyponatremia / 1050
- Conditions
- Hyponatremia
- Keywords
- Hyponatremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Jun 2011 (estimated)
- 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.
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.
Detailed description
Alterations in plasma sodium concentration (sodium ratio and solvent) are very common in clinical practice. Since plasma sodium concentration is a major determinant of plasma osmolality, it will determine the balance of the different body fluids compartments.
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 pseudohyponatremia is an artifact of measuring the concentration of sodium in the context of a growth 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 hyponatremias.
The hypotonic hyponatremia is the one considered to be true. It 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). It is associated with increased morbidity and mortality (18% in hospitalized patients). It can be the cause of serious illness that requires immediate attention or be a marker of morbidity and mortality for underlying diseases (congestive heart failure, liver cirrhosis).
Hyponatremia can occur in a wide range of patients, from asymptomatic with good tolerance to the critically ill. Symptoms may be mild or severe, and none is specific. They are mainly neurological and generally reflect dysfunction associated with cerebral edema. They are caused due to the magnitude of the alteration of plasma sodium concentration and the system speed.
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. Traditionally, the initial assessment and treatment are suboptimal in the descriptive series.
We have not found in the literature any systematic record of patients with abnormalities in the sodium concentration in both inpatients and outpatients, except for a record of pharmacological effects. We 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.
We also have not found any 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.
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 Disnatremias epidemiological data in our environment, risk factors, assessment and monitoring of survival, complications and recurrences. We have no references in the literature that talk about the behaviour 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. We believe that this knowledge will allow us to design studies to optimize and standardize the diagnostic strategies, evaluation and treatment, resulting in a benefit for the affected population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with hyponatremia
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Signs and symptoms Hospital Length of Stay Mortality Therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
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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.
Diego H Giunta, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia, run by Hospital Italiano de Buenos Aires at 1 site 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2019.