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
1 other identifier
observational
31,740
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 27, 2020
CompletedFirst Posted
Study publicly available on registry
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedJune 1, 2020
May 1, 2020
9.5 years
May 27, 2020
May 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
All-cause mortality
1 January 2011 through 1 July 2016
Study Arms (2)
Cases
Controls
Matched (5 controls per case) by date of birth +/- 180 days.
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2020
First Posted
June 1, 2020
Study Start
January 1, 2011
Primary Completion
July 1, 2020
Study Completion
August 1, 2020
Last Updated
June 1, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share
We are unfortunately unable to share individual participant data, as our data source comprises sensitive information from electronic medical records and national registries.