Trial Outcomes & Findings for An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain (NCT NCT02548845)
NCT ID: NCT02548845
Last Updated: 2018-08-06
Results Overview
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
Recruitment status
COMPLETED
Target enrollment
70 participants
Primary outcome 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)
Results posted on
2018-08-06
Participant Flow
Participant milestones
| Measure |
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)
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain
Baseline characteristics by cohort
| Measure |
Oncology Patients With Hyponatraemia
n=70 Participants
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)
|
|---|---|
|
Age, Continuous
|
64.1 years
STANDARD_DEVIATION 13.42 • n=5 Participants
|
|
Sex: Female, Male
Female
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21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
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70 Participants
n=5 Participants
|
|
Weight
|
68.4 kg
STANDARD_DEVIATION 13.00 • n=5 Participants
|
|
Height
|
1.656 meters
STANDARD_DEVIATION 0.1031 • n=5 Participants
|
|
Body Mass Index
|
25.075 kg/m2
STANDARD_DEVIATION 4.3126 • n=5 Participants
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PRIMARY outcome
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)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
Outcome measures
| Measure |
Oncology Patients With Hyponatraemia
n=70 Participants
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)
|
Participant NOT Treated According to SEOM Algorithm
Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH not according to the SEOM algorithm.
|
|---|---|---|
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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)
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20 Participants
|
—
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SECONDARY outcome
Timeframe: Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)Population: 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)
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 \[censored patients\]).
Outcome measures
| Measure |
Oncology Patients With Hyponatraemia
n=19 Participants
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)
|
Participant NOT Treated According to SEOM Algorithm
n=47 Participants
Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH not according to the SEOM algorithm.
|
|---|---|---|
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Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Days)
|
5 Days
Interval 3.0 to 15.0
|
4 Days
Interval 2.0 to 7.0
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SECONDARY outcome
Timeframe: Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)Population: 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.
Outcome measures
| Measure |
Oncology Patients With Hyponatraemia
n=8 Participants
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)
|
Participant NOT Treated According to SEOM Algorithm
n=14 Participants
Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH not according to the SEOM algorithm.
|
|---|---|---|
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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.
|
14.5 Hours
Interval 5.0 to 35.0
|
15.5 Hours
Interval 7.0 to 181.0
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SECONDARY outcome
Timeframe: Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)Outcome measures
| Measure |
Oncology Patients With Hyponatraemia
n=20 Participants
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)
|
Participant NOT Treated According to SEOM Algorithm
n=50 Participants
Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH not according to the SEOM algorithm.
|
|---|---|---|
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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
|
16.5 Days
Interval 8.0 to 27.0
|
9.5 Days
Interval 7.0 to 22.0
|
SECONDARY outcome
Timeframe: Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)Population: 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)
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 \[censored patients\]).
Outcome measures
| Measure |
Oncology Patients With Hyponatraemia
n=17 Participants
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)
|
Participant NOT Treated According to SEOM Algorithm
n=15 Participants
Adult oncology patients who have been treated for ≥ 1 episode of hyponatraemia secondary to the SIADH not according to the SEOM algorithm.
|
|---|---|---|
|
Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Hours)
|
80.5 hours
Interval 38.3 to 331.4
|
134.6 hours
Interval 33.2 to 444.9
|
Adverse Events
Oncology Patients With Hyponatraemia
Serious events: 10 serious events
Other events: 7 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Oncology Patients With Hyponatraemia
n=70 participants at risk
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)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
2/70 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Ascites
|
1.4%
1/70 • Number of events 1 • 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.
|
|
Psychiatric disorders
Listless
|
1.4%
1/70 • Number of events 1 • 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.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
1.4%
1/70 • Number of events 1 • 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.
|
|
Cardiac disorders
Tachycardia
|
1.4%
1/70 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
3/70 • Number of events 3 • 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.
|
|
General disorders
Death
|
2.9%
2/70 • Number of events 2 • 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.
|
|
Psychiatric disorders
Delirium
|
1.4%
1/70 • Number of events 1 • 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.
|
|
General disorders
General physical health deterioriation
|
1.4%
1/70 • Number of events 1 • 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.
|
|
General disorders
Oedema peripheral
|
1.4%
1/70 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
1/70 • Number of events 1 • 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.
|
|
General disorders
Pain
|
1.4%
1/70 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
1/70 • Number of events 1 • 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.
|
|
Nervous system disorders
Seizure
|
1.4%
1/70 • Number of events 1 • 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.
|
|
Nervous system disorders
Headache
|
1.4%
1/70 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Oncology Patients With Hyponatraemia
n=70 participants at risk
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)
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
2.9%
2/70 • Number of events 2 • 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.
|
|
General disorders
Pain
|
2.9%
2/70 • Number of events 2 • 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.
|
|
General disorders
Asthenia
|
2.9%
2/70 • Number of events 3 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.9%
2/70 • Number of events 2 • 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.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
2/70 • Number of events 2 • 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.
|
Additional Information
Medical Department
Otsuka Pharmaceutical Europe Ltd.
Phone: +44(0)2037475000
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER