The aim of this trial is therefore to determine the effects on mortality and rehospitalization rate of a targeted correction of plasma sodium concentration in addition to current standard care in hospitalized hyponatremic patients.
ID
Source
Brief title
Condition
- Heart failures
- Hypothalamus and pituitary gland disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the combined risk of death or rehospitalization within
30 days.
Secondary outcome
• Mortality within 30 days and 1 year
• Rehospitalization within 30 days and 1 year
• Time to death in days
• Time to first re-hospitalization in days
• Length of index hospital stay in days
• Number of falls within 30 days
• Number of fractures within 30 days and 1 year
• Sodium normalization rate at discharge of index hospitalisation
• Change of plasma sodium level from study inclusion until discharge of index
hospitalisation
• Change of plasma sodium level during the hospitalization
• Maximum sodium correction during index hospitalisation
• Time in days until first sodium normalization during index hospitalisation
• Time in days spent in normonatremia during index hospitalisation
Background summary
Hyponatremia is the most common electrolyte disorder with a prevalence of up to
30% in hospitalized patients. While treatment of acute hyponatremia with severe
clinical symptoms due to cerebral edema is undisputed and straightforward,
hyponatremia in general is usually considered asymptomatic or not clinically
relevant. Accordingly, a recent observational study showed that appropriate
laboratory tests to evaluate the etiology of hyponatremia were obtained in less
than 50% of patients, leading to 75% of patients being still hyponatremic at
discharge.
This is problematic in the context of increasing evidence, revealing an
association of chronic hyponatremia with adverse effects such as gait
alterations and falls, attention deficits, bone loss and fractures as well as
disease-associated morbidity leading to increased rates of readmissions and
mortality. Yet, there is a complete lack of randomized clinical trials with the
primary aim to investigate whether correction of plasma sodium concentration
counteracts the elevated risk of rehospitalization and mortality.
Study objective
The aim of this trial is therefore to determine the effects on mortality and
rehospitalization rate of a targeted correction of plasma sodium concentration
in addition to current standard care in hospitalized hyponatremic patients.
Study design
Pragmatic randomized (1:1 ratio) controlled, superiority, parallel-group
international multi-center study with blinded outcome assessment.
Intervention
Targeted correction of plasma sodium concentration in addition to current
standard care during index hospitalisation
Study burden and risks
Basic treatment of hyponatremia involves fluid restriction, saline infusions,
diuretics or administration of oral urea. Those treatments have been known for
years and are generally well tolerated, thus we estimate the risk of this study
intervention as minor.
Dr Molewaterplein 40
Rotterdam 3000 CA
NL
Dr Molewaterplein 40
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
All adult hospitalised patients with hypotonic hyponatremia <130mmol/l
Exclusion criteria
• Severe symptomatic hyponatremia in need of intensive care treatment and / or
of acute correction with 3% saline
• Non-hypotonic hyponatremia with plasma osmolality >300 mOsm
• End of life care (palliative treatment)
• End stage kidney disease (dialysis)
• Acute liver failure
• Wernicke encephalopathy
• Hepatic encephalopathy during last 2 months
• Hepatorenal syndrome
• Patients in the isolation ward due to haematological diseases
• Pregnancy / breastfeeding
• Patients hospitalized for a predetermined fixed duration of 3 days or less
(e.g. inpatient chemotherapy treatment)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL70054.078.19 |