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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 Patient

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

Detailed Summary:
Sponsor: Otsuka Pharmaceutical Europe Ltd

Current Primary Outcome: Number of patients managed according to the SEOM algorithm (as a result adhrence 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to sodium level improvement (depending on baseline sodium level: mild, moderate or severe hyponatraemia) for patients 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) ]
    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
  • 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) ]


Original Secondary Outcome: Same as current

Information By: Otsuka Pharmaceutical Europe Ltd

Dates:
Date Received: September 7, 2015
Date Started: December 2015
Date Completion:
Last Updated: July 21, 2016
Last Verified: July 2016