Clinical trial · Observational
An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyponatremia | — | UNRESOLVED | — |
| Syndrome of Inappropriate ADH (SIADH) Secretion | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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)
- description
- 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 outcomes (4)
- 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)
- description
- 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 \[censored patients\]).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available