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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
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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]). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Department | Otsuka Europe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Castellon | Spain | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Oncology Patients With Hyponatraemia | Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH (defined as a serum sodium level <135 mmol/L) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oncology Patients With Hyponatraemia | Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH (defined as a serum sodium level <135 mmol/L) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 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) |
|
From the onset of the hyponatraemia episode until 6 weeks afterwards
Any untoward medicinal occurrence in a patient administered a medicinal product and which does not necessarily have a causal relationship with this treatment (Directive 2001/83/EC amended by Directive 2010/ 84/ EU). An AE can therefore be any unfavourable and unintended sign (e.g., abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not it is considered causally related to the medicinal product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oncology Patients With Hyponatraemia | Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH (defined as a serum sodium level <135 mmol/L) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDra (18.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDra (18.0) | Systematic Assessment |
Recruitment problems leading to smaller sample size than expected (70 patients vs 100). A priori, the impact on precision was considered acceptable (95% confidence interval equal to ± 10.0% with 100 patients vs ± 11.7% with 70 patients).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Department | Otsuka Pharmaceutical Europe Ltd. | +44(0)2037475000 |
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| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| D007177 | Inappropriate ADH Syndrome |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010900 | Pituitary Diseases |
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| 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) |
| 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 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) |
| Madrid |
| Spain |
| Santiago de Compostela | Spain |
| Seville | Spain |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | meters |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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]). | The overall number of patients analysed represents the number of participants for which the data (time in days) was available. As a retrospective chart review, there were some missing data in this outcome measure (date of improvement in this case) | Posted | Median | 95% Confidence Interval | Days | 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. | In this analysis, only the 22 patients who were candidate for chemotherapy during the study period were included, this explains the difference with the total number of participants. | Posted | Median | 95% Confidence Interval | Hours | 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 | Posted | Median | 95% Confidence Interval | Days | 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]). | The overall number of patients analysed represents the number of participants for which the data (time in hours) was available. As a retrospective chart review, there were some missing data in this outcome measure (time of improvement in this case) | Posted | Median | 95% Confidence Interval | hours | Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode) |
|
|
|
| 5 |
| 70 |
| 10 |
| 70 |
| 7 |
| 70 |
| Ascites | Gastrointestinal disorders | MedDra (18.0) | Systematic Assessment |
|
| Listless | Psychiatric disorders | MedDra (18.0) | Systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | MedDra (18.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDra (18.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra (18.0) | Systematic Assessment |
|
| Death | General disorders | MedDra (18.0) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDra (18.0) | Systematic Assessment |
|
| General physical health deterioriation | General disorders | MedDra (18.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDra (18.0) | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDra (18.0) | Systematic Assessment |
|
| Pain | General disorders | MedDra (18.0) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDra (18.0) | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDra (18.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDra (18.0) | Systematic Assessment |
|
| Pain | General disorders | MedDra (18.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDra (18.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDra (18.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDra (18.0) | Systematic Assessment |
|
As a multicentre study, the first publication shall be based on consolidated analysed data from all centres, i.e. the publication of results from individual institution/Investigator is not allowed before the publication of the full study results.
The PI agrees to give the sponsor 60 days to review the communications. If case of propietary information inadvertenly divulged, intellectual property rights at risk or inaccurate information presented, changes can be required by the sponsor.
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |