What?
The INTOXICATE (ex-TOXIC-Europe) study is a multicentre, observational study in Europe and other continents, on the outcomes and prognosis of intoxicated patients in Intensive Care Units.
Why?
Our first research of long-term outcomes in intoxicated ICU patients was published in 2014. It gave us the idea that not all intoxicated patients needed to be admitted to the ICU. Quite a few do not have a complicated course of their disease. Hereafter, we have published several articles on prediction models and outcome.
No database exists in Europe to confirm or infirm this impression. The objective of the INTOXICATE study is to describe, in a large population of ICU patients, the types of, outcomes, management and prognosis factors of acute intoxications. To sample a representative cohort, we intend to recruit about 200 ICUs with as many European countries as possible (ICUs in other continents are also welcome). Here, some examples of questions that will be answered:
– what is the in-hospital mortality of intoxicated ICU patients in Europe and other continents?
-what is the 30-day mortality of intoxicated ICU patients in Europe and other continents?
-what is the frequency of specific groups of intoxications?
-what are the current approaches taken to treat autely intoxicated patients?
-what are the prognostic factor (patient, institutional, medical practice) of a “poor outcome” in intoxicated patients??
-what are the prognostic factors of specific intoxications? e.g. validation of the Ibister nomogram.
When?
Inclusions will continue until summer 2023 in ICUs across Europe and other continents.
What data is required?
Data to be recorded include patient demographics, data on exposure, comorbidities, severity of the intoxication, organ failure, vital signs at the Emergency Room and at ICU admission, prognostic scores like APACHE or SOFA , lab results, ECGs, and treatments administered before the admission and during the ICU stay.
Therapeutic intervention
The study is purely observational in nature; no interventions are planned.
Study population
Inclusion criteria:
-patient admitted to the ICU/HCU from Emergency Department, ambulance or from another ward
-intoxication as primary reason for ICU/HCU admission
-stay at the ICU/HDU during 4 hours or longer
-adult patients (≥ 18 years of age) .
Exclusion criteria: age < 18 years, stay shorter than 4 hours at the ICU, intoxication is not the primary reason for ICU admission.
Duration
1-year study with follow-up for survival at 30 days after ICU admission.
Do I need IRB approval?
Ethics approval may or may not be required depending on what country your ICU/HDU is located. IRB approval must be obtained for each centre if required by its local regulations. In most countries, a National Coordinator will liaise with participating centres, helping you to obtain IRB approval.
Is a data sharing agreement required?
Yes, to use your data for the study, we need a signed data sharing agreement.
How are the data collected and managed?
Data will be entered by the site investigators in electronic report forms (eCRF) in a digital database (Castor EDC) . No patient identifying information will be collected, no personal data such as name or date of birth will recorded in the eCRF. Data encryption will be used for pseudonymisation of the data.
Data will be verified for consistency and completeness by the team of the coordinating center (UMC Utrecht). Then, data will be exported as anonymous data that cannot be linked to individual subjects and stored securely to be analysed. All procedures regarding data management will comply with EU directive on data protection 95/46/EC.
Who owns and can access the collected data?
Each site investigator is responsible for his/her own data and may request an export of this data after the database is locked. The request should be addressed to the Principal Investigator.
Is there any financial compensation?
No. Participation in the study is completely voluntary.
What about authorship?
Results from the study will be published in scientific papers submitted to peer-reviewed journals. Authorship of the manuscripts will follow the International Committee of Medical Journal Editors (ICMJE) recommendations.
All National Coordinators will have their efforts recognised by being authors if they meet the ICMJE criteria and if they promote the enrolment of a significant number of units in their country, with complete data collection of at least 20 patients per unit.
The primary analysis of the study will be submitted preferentially to a journal that allows all site investigators to be added as author or collaborator. If the former is not possible, albeit that a minimum of 10 patients with complete data collection should have been included in the study.
All Site Investigators will be credited in the “INTOXICATE (ex-TOXIC-Europe) Investigators” group authorship or in the acknowledgment section, and as such, listed in Pubmed. Due to the potential high number of centres that we hope will include patients, we have to limit to two names collaborators per unit (the lead investigator and one co-investigator).
Financial support
The project is financed by the Dutch Poisons Center, UMC Utrecht, The Netherlands.
Any further questions?
If you have additional questions, please contact your National Coordinator or the Coordinating Center.