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

NCT02548845 | Completed Results

• 1 other identifier: 156-303-00043
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 4

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

Conditions

Hyponatremia; Syndrome of Inappropriate ADH (SIADH) Secretion

Keywords

hyponatremia; SIADH; Oncologic patients

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• 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)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Europe Ltd: lead

Study Sites (4)

Unknown Facility

Castellon, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Santiago de Compostela, Spain

Location

Unknown Facility

Seville, Spain

Location

MeSH Terms

Conditions

Hyponatremia; Inappropriate ADH Syndrome

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Limitations and Caveats

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).

Results Point of Contact

• Title: Medical Department
• Organization: Otsuka Pharmaceutical Europe Ltd.

+44(0)2037475000

Study Officials

• Medical Department

  Otsuka Europe

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: September 14, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 6, 2018
• Results First Posted: August 6, 2018

Record last verified: 2017-11

Locations

ES (4)