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

Completed

• Conditions: Hyponatremia; Syndrome of Inappropriate ADH (SIADH) Secretion

• Registration Number: NCT02548845
• Lead Sponsor: Otsuka Pharmaceutical Europe Ltd

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-07
• Study First Submitted QC: 2015-09-10
• Study First Posted: 2015-09-14
• Study Start: 2015-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Results First Submitted: 2017-06-01
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-06
• Last Update Submitted: 2017-11-06
• Results First Posted: 2018-08-06
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	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)	Adherence to the algorithm will be evaluated using a pre-defined decision tree that will be provided in the electronic case report form (eCRF) and will be completed by the investigator

Secondary Outcome Measures

Name	Time	Method
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	Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)
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.	Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)
Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Hours)	Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)	Improvement is defined as a change in the baseline sodium level category (mild, moderate or severe) from a worse category to a better category or eunatraemia. Note that the time to improvement of sodium levels was defined as the first date/time of improvement of sodium levels - date/time of collection of serum sodium levels at baseline (for patients where there was an improvement in sodium levels) or as the final date/time of collection of serum sodium levels - date/time of collection of serum sodium levels at baseline (for patients that did not achieve an improvement in sodium levels \[censored patients\]).
Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Days)	Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)	Improvement is defined as a change in the baseline sodium level category (mild, moderate or severe) from a worse category to a better category or eunatraemia. Note that the time to improvement of sodium levels was defined as the first date/time of improvement of sodium levels - date/time of collection of serum sodium levels at baseline (for patients where there was an improvement in sodium levels) or as the final date/time of collection of serum sodium levels - date/time of collection of serum sodium levels at baseline (for patients that did not achieve an improvement in sodium levels \[censored patients\]).