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

Hyponatremia Clinical Trial

— ALGA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02548845
• Other study ID #: 156-303-00043
• Status: Completed
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: November 2017
• Source: Otsuka Pharmaceutical Europe Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyponatremia
• Inappropriate ADH Syndrome
• Syndrome of Inappropriate ADH (SIADH) Secretion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Europe Ltd

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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	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	Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Days)	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]).	Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)
Secondary	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)
Secondary	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)
Secondary	Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Hours)	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]).	Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)