Hyponatremia Clinical Trial
Official title:
Hypotonic Hyponatremia: Criteria for the Correct Classification of Its Etiology and of Patient Volume Status at the Access in the Emergency Department and at the Subsequent Re-evaluation in Hospital Wards
Hyponatremia is the most frequent electrolyte disorder encountered in clinical practice. The
patient approach, however, is still problematic, above all because hyponatremia is a
manifestation correlated to various pathological conditions, with complex etiopathogenesis.
Even though some algorithms have been proposed to correctly assess hyponatremia subtype
classification and patient volume status, there is no single parameter that has proven to be
able alone to perfectly achieve this result.
Hyponatremia is the most frequent electrolyte disorder encountered in clinical practice and
is often associated with increased mortality, morbidity and risk of hospitalization. The
patient approach, however, is still problematic, above all because hyponatremia is a
manifestation correlated to various pathological conditions, with complex etiopathogenesis.
The most commonly used classification of hypotonic hyponatremia is, nowadays, the one
described in a famous review by Kumar and Berl (see Bibliography). Probably the most crucial
point in this classification is represented by the correct assessment of Extracellular Fluid
Volume Status (i.e. hypovolemia, euvolemia, hypervolemia).
Even though some algorithms have been proposed to correctly assess hyponatremia subtype
classification and patient volume status, there is no single parameter that has proven to be
able alone to perfectly achieve this result.
In the current study, the reference test (gold standard) for the definitive assessment of
hyponatremia subtype classification and patient volume status was a post-discharge
re-evaluation of all the available evidence (with the exception of plasma copeptin levels)
carried out by two independent neuroendocrinologists with specific expertise in sodium
disorders. In case of disagreement, the experts proceeded to a discussion and comparison of
their opinions, in order to produce a shared one.
Using this gold standard, the main aims of this observational prospective study were:
1. to estimate the diagnostic accuracy of the clinicians in identifying the subtype of
hyponatremia at the first evaluation of the patients in the ED and then at the admission
to the wards;
2. to evaluate the diagnostic accuracy of the most important methods suggested by the
literature (clinical, imaging, biochemical) for the assessment of Extracellular Fluid
Volume.
In addition to this, in recent years copeptin has been shown to be a promising parameter for
the evaluation of sodium disorders and water imbalances, but its diagnostic role in the
setting of hyponatremic patients is still largely unknown. Therefore, a secondary objective
of the study was to specifically evaluate the utility of copeptin (whose values - as
specified before - were hidden to the neuroendocrinologists in charge of defining the gold
standard diagnoses for each patient) for the assessment of hyponatremia subtype
classification and patient volume status.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06037928 -
Plasma Sodium and Sodium Administration in the ICU
|
||
Recruiting |
NCT04561531 -
Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia.
|
N/A | |
Terminated |
NCT02012959 -
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
|
Phase 3 | |
Recruiting |
NCT02936167 -
Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children
|
N/A | |
Completed |
NCT00621348 -
Maintenance Intravenous Fluids in Children
|
Phase 3 | |
Terminated |
NCT03703713 -
Colloid Osmotic Pressure and Osmolality in Hyponatremia
|
||
Completed |
NCT02926989 -
Intravenous Fluids in Hospitalised Children
|
Phase 4 | |
Terminated |
NCT02959411 -
Tolvaptan for Advanced or Refractory Heart Failure
|
Phase 4 | |
Completed |
NCT02573077 -
An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
|
||
Withdrawn |
NCT02667977 -
Reexamining Hypotonic Intravenous Fluid Use
|
N/A | |
Terminated |
NCT01708811 -
Hyponatremia and Myometrium Contractility. An Invitro Study
|
N/A | |
Withdrawn |
NCT01326429 -
Frequency and Origin of Dysnatremias in the Emergency Department
|
N/A | |
Completed |
NCT01456533 -
Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients
|
N/A | |
Terminated |
NCT01227512 -
Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
|
Phase 3 | |
Recruiting |
NCT06013800 -
Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
|
||
Terminated |
NCT04020926 -
Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function
|
||
Withdrawn |
NCT02442674 -
A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia
|
Phase 3 | |
Completed |
NCT02545101 -
An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH
|
N/A | |
Terminated |
NCT02215148 -
Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients
|
N/A | |
Recruiting |
NCT01748331 -
The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia
|
N/A |