An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain

NCT ID: NCT02548845

Last Updated: 2018-08-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-06-30

Brief Summary

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In 2014, the Spanish Sociedad Española de Oncología Médica (SEOM) algorithm for the treatment of hyponatraemia secondary to to syndrome of inappropriate antidiuretic hormone (SIADH) in oncology patients was developed. Since it is hypothesised that the adherence to the SEOM algorithm is not 100%, the current retrospective non-interventional study will investigate the perceived and actual adherence of participating centres to the SEOM algorithm and its impact on patient outcomes

Detailed Description

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Conditions

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Hyponatremia Syndrome of Inappropriate ADH (SIADH) Secretion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Provision of patient informed consent unless a) not required by local regulations, b) it would represent a non-reasonable effort or c) if the source patient is deceased or untraceable.
* Female and/or male oncology patients aged 18 years and over
* Patients who have experienced at least one occurrence of hyponatraemia secondary to the SIADH.

Exclusion Criteria

* A patient cannot take part in this study if participating in any clinical study in which the medicinal product aims to treat the causes or symptoms of hyponatraemia at the time of the hyponatraemia episode being documented in the current study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Europe Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Department

Role: STUDY_DIRECTOR

Otsuka Europe

Locations

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Castellon, , Spain

Site Status

Madrid, , Spain

Site Status

Santiago de Compostela, , Spain

Site Status

Seville, , Spain

Site Status

Countries

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Spain

Other Identifiers

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156-303-00043

Identifier Type: -

Identifier Source: org_study_id

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