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

NCT ID: NCT04409626

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

31740 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hyponatremia SIADH

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Plasma sodium level (continuous variables)

Intervention Type OTHER

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.

Plasma sodium level (continuous variables)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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REG-2020-05-05

Identifier Type: -

Identifier Source: org_study_id

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