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

Hyponatremia Clinical Trial

Official title:

Is Hyponatraemia a Risk Factor for Mortality in Schizophrenic and Bipolar Patients? Protocol for a Bayesian Causal Inference Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04409626
• Other study ID #: REG-2020-05-05
• Status: Active, not recruiting
• Start date: January 1, 2011
• Est. completion date: August 2020

Study information

• Verified date: May 2020
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31740
• Est. completion date: August 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyponatremia
• SIADH

Intervention

Other:
• Plasma sodium level (continuous variables)
Observational study, so the exposures of interest (5-year mean and minimum plasma sodium) are not administered to the patients. Ultimately, our interest is in hyponatraemia.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	All-cause mortality	1 January 2011 through 1 July 2016