Hyponatraemia and Mortality in Schizophrenic and Bipolar Patients: Protocol for a Bayesian Causal Inference Study

Zealand University Hospital

Status: Unknown

Conditions: Hyponatremia; SIADH

Treatments: Other: Plasma sodium level (continuous variables)

Study type: Observational

Funder types: Other

Identifiers

NCT04409626

REG-2020-05-05

Details and patient eligibility

About

This study seeks to investigate if hyponatraemia be a direct contributor to death in schizophrenic and bipolar patients, and gauge the potential role of somatic comorbidity and psychotropic polypharmacy, with emphasis on antipsychotics and antidepressants.

Enrollment: 31,740 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Source population:

• Danish residents
• At least one International Classification of Diseases version 10 (ICD-10) F2 or F31 diagnosis from a hospital in Region Zealand and the Capital Region (Denmark)

No exclusion criteria.

Trial design

31,740 participants in 2 patient groups

Cases

Treatment:

Other: Plasma sodium level (continuous variables)

Controls

Description:

Matched (5 controls per case) by date of birth +/- 180 days.

Treatment:

Other: Plasma sodium level (continuous variables)