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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hyponatremia; SIADH
• Intervention / Treatment: Other: Plasma sodium level (continuous variables)

• Study Type: Observational
• Enrollment (Anticipated): 31740

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cases:

• Died in our catchment area between 1 January 2011 and 1 July 2016.

Controls:

• 5 controls per case found by risk-set sampling with replacement, matched on date of birth +/- 180 days.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases	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.
Controls; Matched (5 controls per case) by date of birth +/- 180 days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All-cause mortality	1 January 2011 through 1 July 2016

Collaborators and Investigators

• Sponsor: Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 27, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Polypharmacy; Antipsychotics; Causality; Bayesian analysis; Psychotropics
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Hyponatremia
• Other Study ID Numbers: REG-2020-05-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We are unfortunately unable to share individual participant data, as our data source comprises sensitive information from electronic medical records and national registries.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No