Clinical trial NCT02548845: An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain
Official title: An Observational, Retrospective Study to Describe the Extent of Adherence to the Spanish Society of Medical Oncology Algorithm for the Treatment of Hyponatraemia Secondary to SIADH in Oncology Patients in Spain (ALGA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyponatremia
Syndrome of Inappropriate ADH (SIADH) Secretion
Keywords: hyponatremia
SIADH
Oncologic patients
Lead sponsor: Otsuka Pharmaceutical Europe Ltd
Sponsor class: INDUSTRY
First posted: 2015-09-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible patients are oncology patients ≥ 18 years old who had been diagnosed with at least one occurrence of hyponatraemia secondary to the SIADH and who had been managed ein one of the Spanish centres who have implemented the SEOM algorithm.

Brief summary: 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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients Managed According to the SEOM Algorithm (as a Result Adherence to the Algorithm Will be the % of These Patients Among the Total Number of Patients)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 days (follow-up will stop after a maximum of 6 weeks)
Secondary outcomes:
measure: Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Days)
timeFrame: Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)
measure: Time to Initiation or Re-initiation of Chemotherapy (Since the Start of the Hyponatraemia Episode) in Patients Candidate for Chemotherapy Who Were and Were Not Treated in Adherence With the SEOM Algorithm.
timeFrame: Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)
measure: Length of Hospitalisation (Measured From the Start of the Hyponatraemia Episode to Discharge) for Patients Who Were and Were Not Treated in Adherence With the Algorithm
timeFrame: Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)
measure: Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Hours)
timeFrame: Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)
Other outcomes:
Locations:
city: Castelló de la Plana
country: Spain
city: Madrid
country: Spain
city: Santiago de Compostela
country: Spain
city: Sevilla
country: Spain
Study officials:
affiliation: Otsuka Europe
name: Medical Department
role: STUDY_DIRECTOR
References: