Hyponatremia Clinical Trial
— SAMPLEOfficial title:
A Non Interventional, Retrospective Study on Real World Usage and Treatment Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to the SIADH.
Verified date | February 2018 |
Source | Otsuka Pharmaceutical Europe Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a retrospective chart review non-interventional study designed to collect real world data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone (SIADH) secretion.
Status | Completed |
Enrollment | 100 |
Est. completion date | April 2016 |
Est. primary completion date | April 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 take a non reasonable effort or c) if the source patient is deceased or untraceable. - Female and/or male patients aged 18 years and over. - Patients who received at least 2 doses of tolvaptan, for the treatment of one occurrence of hyponatraemia secondary to SIADH. Exclusion Criteria: - A patient cannot take part in this study if participating in any other 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Otsuka Pharmaceutical Europe Ltd |
Germany, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Concomitant Treatments to Tolvaptan (Number and Percentage of Subjects Taking Concomitant Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Only medications taken by more than 5% of the study population are presented | From baseline (tolvaptan treatment initiation) up to 6 weeks after treatment initiation | |
Other | Prior Treatments Before Tolvaptan (Number and Percentage of Subjects Taking Prior Medications Will be Summarized by Anatomical Therapeutic Chemical (ATC) Classification) | Only medications taken by more than 5% of the study population are presented | From 12 months up to baseline (tolvaptan treatment initiation) | |
Primary | Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge | The primary variable of the study was the change in sodium levels from baseline to discharge or the final available measurement for patients who were not discharged (up to 6 weeks after treatment initiation). | From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment) | |
Secondary | Change in Sodium Levels 24 Hours After Treatment Initiation | Change in sodium level from last value prior to receiving tolvaptan until last available measurement within 24 hours of initiation of tolvaptan | From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards | |
Secondary | Change in Sodium Levels 6 Weeks After Treatment Initiation | Change in sodium level from last value prior to receiving tolvaptan until last available measurement up to week 6 | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | |
Secondary | Time (Hours) to Sodium Normalisation | Time (hours) to sodium normalisation, defined as a serum sodium level > 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation). | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | |
Secondary | Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,) | Primary disease diagnoses leading to SIADH by evaluation of diagnosis information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records | Baseline | |
Secondary | Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population) | symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records | Baseline | |
Secondary | Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,) | specialty of the clinician prescribing tolvaptan by evaluation of details of the physician who prescribed tolvaptan for the episode of hyponatraemia being captured in the study from the patient's medical records | Baseline | |
Secondary | Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study | Average daily dose of tolvaptan used and treatment duration (expressed in days) for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment). For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered). |
From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | |
Secondary | Time (Days) to Sodium Normalisation | Time (days) to sodium normalisation, defined as a serum sodium level > 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation). | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | |
Secondary | Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records | Baseline | |
Secondary | Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study | Average treatment duration for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment). For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered). |
From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06037928 -
Plasma Sodium and Sodium Administration in the ICU
|
||
Recruiting |
NCT04561531 -
Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia.
|
N/A | |
Terminated |
NCT02012959 -
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
|
Phase 3 | |
Recruiting |
NCT02936167 -
Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children
|
N/A | |
Completed |
NCT00621348 -
Maintenance Intravenous Fluids in Children
|
Phase 3 | |
Terminated |
NCT03703713 -
Colloid Osmotic Pressure and Osmolality in Hyponatremia
|
||
Completed |
NCT02926989 -
Intravenous Fluids in Hospitalised Children
|
Phase 4 | |
Terminated |
NCT02959411 -
Tolvaptan for Advanced or Refractory Heart Failure
|
Phase 4 | |
Completed |
NCT02573077 -
An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
|
||
Withdrawn |
NCT02667977 -
Reexamining Hypotonic Intravenous Fluid Use
|
N/A | |
Terminated |
NCT01708811 -
Hyponatremia and Myometrium Contractility. An Invitro Study
|
N/A | |
Withdrawn |
NCT01326429 -
Frequency and Origin of Dysnatremias in the Emergency Department
|
N/A | |
Completed |
NCT01456533 -
Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients
|
N/A | |
Terminated |
NCT01227512 -
Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
|
Phase 3 | |
Recruiting |
NCT06013800 -
Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
|
||
Terminated |
NCT04020926 -
Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function
|
||
Withdrawn |
NCT02442674 -
A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia
|
Phase 3 | |
Terminated |
NCT02215148 -
Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients
|
N/A | |
Recruiting |
NCT01748331 -
The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia
|
N/A | |
Not yet recruiting |
NCT01716611 -
Tolvaptan for Hyponatremia in Cirrhotic Patients With Ascites
|
Phase 4 |