Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Other

If ‘other’, further details on the scope of the study

To compare the degree of adherence to current recommendations (EXTRIP criteria) on the management of lithium poisoning

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Multicentre retrospective observational international study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(N05AN) Lithium
Lithium

Medical condition to be studied

Toxicity to various agents
Population studied

Short description of the study population

Patients aged 18 years or older diagnosed with lithium poisoning identified from 2012 to 2022.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Patients with lithium poisoning

Estimated number of subjects

150
Study design details

Main study objective

To compare the degree of adherence to current recommendations (EXTRIP criteria) on the management of lithium poisoning in the participating centres. Others objectives: - To determine the effectiveness of renal replacement techniques - To quantify the incidence of patients with SILENT - To describe different clinical or analytical predictors of severity

Outcomes

Variables to establish adherence to EXTRIP recommendations. - Percentage of patients treated with RRT meeting EXTRIP criteria. - Percentage of patients treated with RRT who do not meet the EXTRIP criteria. - Percentage of patients not treated with RRT meeting EXTRIP criteria. - Percentage of patients not treated with RRT who do not meet the EXTRIP criteria. -Percentage of patients developing SILENT at 60 days follow-up. -Percentage of patients who die by day 30. -Percentage of patients discharged by day 30. -Percentage of patients with symptoms suggestive of SILENT at discharge from ICU and/or hospital. -Total days of stay in ICU/ of hospital stay.

Data analysis plan

Descriptive analysis will be performed for all study variables, with appropriate analyses depending on the nature of each of the variables: The incidence in exposed (cohort treated with renal replacement therapy) and unexposed (untreated cohort) individuals will be calculated for each of the effectiveness variables listed above.) From these, measures of association will be calculated for each of the variables: relative risk (RR), absolute risk reduction (ARR) and relative risk reduction (RRR), with their 95% CIs. Different hypothesis tests will be applied depending on the nature of the variable. These tests are: Fisher's exact test for categorical variables, Student's t-test for continuous variables and Mann-Whitney U-test for ordinal variables. Logistic regression models will be used to identify predictors of non-response and serious adverse events. Multivariate stepwise logistic regression analysis will be used to identify any independent baseline predictors.