Spanish and Irish study of lithium toxicity and extracorporeal removal (SILITOX Study)

Study identification

• EU PAS number:
  EUPAS103542
• Study ID:
  103543
• Official title and acronym:
  Spanish and Irish study of lithium toxicity and extracorporeal removal (SILITOX Study)
• DARWIN EU® study:
  No
• Study countries:
  Ireland

  Spain
• Study description:
  Lithium's narrow therapeutic index continues to make it a difficult drug to manage, and its potential toxicity a major concern when indicated. The goals of treatment of lithium poisoning are to prevent death and to avoid lithium irreversible neurotoxicity syndrome (SILENT). Treatment of lithium toxicity includes fluid therapy to correct hypovolaemia and increase renal elimination of lithium (even in states of euvolemia), digestive decontamination in certain circumstances, and haemodialysis in cases of severe toxicity. Haemodialysis is the treatment of choice for severe lithium toxicity, as it is easily dialysable due to its low molecular weight, negligible protein binding and small volume of distribution. According to the recommendations of the EXTRIP workgroup the decision on when to use extracorporeal therapy should take into account Li+, renal function, the patient's clinical situation (symptoms of lithium toxicity) and the availability of extracorporeal therapy. Although this treatment and its indications are well defined, the degree of application of these renal replacement therapies remains controversial. In this context, a retrospective observational multicentre international study is proposed to evaluate the degree of adherence to the current EXTRIP recommendations regarding renal replacement therapies in the treatment of lithium poisoning, as well as to determine predictors of mortality and hospital stay at 30 days and the incidence of the development of irreversible lithium neurotoxicity (SILENT) at ICU discharge, hospital discharge and at 60 days.
• Study status:
  Finalised

Research institutions and networks

Institutions

Clinical Pharmacology Service, Puerta de Hierro-Majadahonda University Hospital (HUPHM)

Spain

Clinical Pharmacology Service, Puerta de Hierro-Majadahonda University Hospital (HUPHM)

Spain

Hospital Universitario Son Espases Spain, Hospital Clinic de Barcelona Spain, Hospital Sant Joan Despí Spain, Hospital del Mar Spain, Hospital Universitario Dr. Josep Trueta Spain, Mater Misericordiae University Hospital Ireland

Study timelines

Date when funding contract was signed

Planned: 13/02/2023

Actual: 13/02/2023

Study start date

Planned: 01/03/2023

Actual: 14/02/2023

Data analysis start date

Planned: 01/06/2023

Actual: 14/02/2023

Date of interim report, if expected

Planned: 01/08/2023

Actual: 14/02/2023

Date of final study report

Planned: 01/10/2023

Actual: 14/02/2023

Sources of funding

Other

More details on funding

The study is not funded

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable