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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04409626
Recruitment Status : Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

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.

Condition or disease Intervention/treatment
Hyponatremia SIADH Other: Plasma sodium level (continuous variables)

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Study Type : Observational
Estimated Enrollment : 31740 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Is Hyponatraemia a Risk Factor for Mortality in Schizophrenic and Bipolar Patients? Protocol for a Bayesian Causal Inference Study
Actual Study Start Date : January 1, 2011
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

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.




Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 January 2011 through 1 July 2016 ]
    All-cause mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT04409626    
Other Study ID Numbers: REG-2020-05-05
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zealand University Hospital:
Causality
Bayesian analysis
Antipsychotics
Psychotropics
Polypharmacy
Additional relevant MeSH terms:
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Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases