Targeted correction of plasma sodium levels in hospitalized patients with hyponatremia: a randomized, controlled, parallel-group trial with blinded outcome assessment

Recruiting

Conditions: electrolyte disorder
salt-water disorder
10019280
10021112
10038430

Registration Number: NL-OMON54970

Lead Sponsor: efrologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1000

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is the combined risk of death or rehospitalization within<br /><br>30 days. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Mortality within 30 days and 1 year<br /><br>• Rehospitalization within 30 days and 1 year<br /><br>• Time to death in days<br /><br>• Time to first re-hospitalization in days<br /><br>• Length of index hospital stay in days<br /><br>• Number of falls within 30 days<br /><br>• Number of fractures within 30 days and 1 year<br /><br>• Sodium normalization rate at discharge of index hospitalisation<br /><br>• Change of plasma sodium level from study inclusion until discharge of index<br /><br>hospitalisation<br /><br>• Change of plasma sodium level during the hospitalization<br /><br>• Maximum sodium correction during index hospitalisation<br /><br>• Time in days until first sodium normalization during index hospitalisation<br /><br>• Time in days spent in normonatremia during index hospitalisation</p><br>