HyponatremiaALGANCT02548845

An Observational Study to Describe the Adherence to the SEOM Algorithm for the Treatment of Hyponatraemia in Spain

An observational study of Hyponatremia and Syndrome of Inappropriate ADH (SIADH) Secretion, run by Otsuka Pharmaceutical Europe Ltd at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
How many people: 70 participants
Where: 4 sitesSpain
Study dates: Dec 2015to Jun 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

Study site
Castellon
Study site
Madrid
Study site
Santiago de Compostela
Study site
Seville

Other trials in Spain

About this study

Official title: 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)

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: Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
Keywords: hyponatremia, SIADH, Oncologic patients
Medical subject headings: Hyponatremia, Inappropriate ADH Syndrome

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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)

Secondary outcomes (4)

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]).
Measured: 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.
Measured: 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
Measured: 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]).
Measured: Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2015Jun 2016

First posted14 Sep 2015 (estimated)
Study startDec 2015
Primary completionJun 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HyponatremiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02548845
Sponsor's protocol ID: 156-303-00043
Acronym: ALGA
Status last verified: Nov 2017
First submitted: 7 Sep 2015
Last updated: 6 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
Hyponatremia, Osmotic Demyelination Syndrome

All Hyponatremia trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02548845
Acronym / sponsor ID: ALGA / 156-303-00043
Conditions: Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion
Keywords: hyponatremia, SIADH, Oncologic patients
Study type: Observational
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Europe LtdIndustry (pharma, biotech, devices)
Study start: Dec 2015
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 14 Sep 2015 (estimated)
Results: Posted 6 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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.

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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)
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)
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

4 secondary outcomes

Time to Sodium Level Improvement for Patients Who Were and Were Not Treated in Adherence With the SEOM Algorithm (Days)
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: Longitudinal (up to discharge or a maximum of 6 weeks after onset of hyponatremia episode)

Results and safety

Results posted to the registry on 6 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oncology Patients With Hyponatraemia	70	70

Primary outcome: 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)

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). Count of participants. Unit: Participants

Measure	Oncology Patients With Hyponatraemia n = 70
Value	20

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the onset of the hyponatraemia episode until 6 weeks afterwards. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oncology Patients With Hyponatraemia	10 of 70 (14.3%)	7 of 70 (10%)	5 of 70

Limitations and caveats (from the sponsor): 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).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hyponatremia

RecruitingPhase 3
Systematic Use of DDAVP to Prevent Serum Sodium Overcorrection in Severe Hyponatremia
Hyponatremia
Enrolling by invitationObservational study
International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
Hyponatremia, Osmotic Demyelination Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Department study director

Otsuka Europe

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hyponatremia and Syndrome of Inappropriate ADH (SIADH) Secretion, run by Otsuka Pharmaceutical Europe Ltd at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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) (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02548845.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.