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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54970
Enrollment
1000
Registered
2019-12-11
Start date
2020-02-20
Completion date
Unknown
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

electrolyte disorder salt-water disorder

Interventions

Targeted correction of plasma sodium concentration in addition to current standard care during index hospitalisation

Sponsors

Nefrologie
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All adult hospitalised patients with hypotonic hyponatremia

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
The primary outcome is the combined risk of death or rehospitalization within 30 days.

Secondary

MeasureTime frame
• 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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 15, 2026