Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
Conditions
Keywords
hyponatremia, SIADH, Oncologic patients
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
Interventions
None listed
Sponsors
Otsuka Pharmaceutical Europe Ltd
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 \[censored patients\]). |
| 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) | 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 \[censored patients\]). |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | Oncology Patients With Hyponatraemia |
|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 13.42 |
| Body Mass Index | 25.075 kg/m2 STANDARD_DEVIATION 4.3126 |
| Height | 1.656 meters STANDARD_DEVIATION 0.1031 |
| Region of Enrollment Spain | 70 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 49 Participants |
| Weight | 68.4 kg STANDARD_DEVIATION 13 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 70 |
| other Total, other adverse events | 7 / 70 |
| serious Total, serious adverse events | 10 / 70 |
Outcome results
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
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Oncology Patients With Hyponatraemia | 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) | 20 Participants |
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
Time frame: Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oncology Patients With Hyponatraemia | 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 |
| Participant NOT Treated According to SEOM Algorithm | 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 | 9.5 Days |
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oncology Patients With Hyponatraemia | 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 |
| Participant NOT Treated According to SEOM Algorithm | 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. | 15.5 Hours |
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 \[censored patients\]).
Time frame: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oncology Patients With Hyponatraemia | Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Days) | 5 Days |
| Participant NOT Treated According to SEOM Algorithm | Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Days) | 4 Days |
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 \[censored patients\]).
Time frame: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oncology Patients With Hyponatraemia | Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Hours) | 80.5 hours |
| Participant NOT Treated According to SEOM Algorithm | Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Hours) | 134.6 hours |