The INTOXICATE study: methodology and preliminary results of a prospective observational study

Abstract

Background: There is currently no practice-based, multicenter database of poisoned patients admitted to intensive care units (ICUs). The INTOXICATE study, endorsed by the ESICM and EAPCCT, aimed to determine the rate of eventful admissions among acutely intoxicated adult ICU patients.

Methods: Ethical approval was obtained for this multicenter, prospective observational study, and data-sharing agreements were signed with each participating center. An electronic case report form was used to collect data on patient demographics, exposure, clinical characteristics, investigations, treatment, and in-hospital mortality data. The primary outcome, 'eventful admission', was a composite outcome defined as the rate of patients who received any of the following treatments in the first 24 h after the ICU admission: oxygen supplementation with a FiO2 > 40%, mechanical ventilation, vasopressors, renal replacement therapy (RRT), cardiopulmonary resuscitation, antidotes, active cooling, fluid resuscitation (> 1.5 L of intravenous fluid of any kind), sedation, or who died in the hospital.

Results: Seventy-eight ICUs, mainly from Europe, but also from Australia and the Eastern Mediterranean, participated. A total of 2,273 patients were enrolled between November 2020 and June 2023. The median age of the patients was 41 years, 72% were exposed to intoxicating drugs. The observed rate of patients with an eventful ICU admission was 68% (n = 1546/2273 patients). The hospital mortality was 4.5% (n = 103/2273).

Conclusions: The vast majority of patients survive, and approximately one third of patients do not receive any ICU-specific interventions after admission in an intensive care unit for acute intoxication. High-quality detailed clinical data have been collected from a large cohort of acutely intoxicated ICU patients, providing information on the pattern of severe acute poisoning requiring intensive care admission and the outcomes of these patients.

Trial registration: OSF registration ID: osf.io/7e5uy.

Keywords: Critical care outcomes; Database management systems; Intensive care units; Poisoning; Toxicology.

Fig. 1

Study Flow Diagram for units. Data entered by local investigators (black outlines), reasons for exclusion (purple), and study phase (blue) are represented

Fig. 2

Study Flow Diagram for patients in the main analysis. An “eventful ICU admission” was defined as receiving an ICU intervention within the first 24 h after ICU admission or in-hospital death. An ICU intervention was defined as receiving any of the following treatments: oxygen supplementation with a FiO2. 40%, mechanical ventilation, vasopressors, renal replacement therapy (RRT), cardiopulmonary resuscitation, antidote, active cooling, fluid resuscitation (> 1.5 L of intravenous fluid of any kind), and sedation. ICU intervention before ICU admission was defined as receiving mechanical ventilation or cardiopulmonary resuscitation or vasopressors (over at least 1 h) before ICU admission

Fig. 3

Study Flow Diagram for patients in the post-hoc analysis (using alternative definitions 1 and 2 for “eventful ICU admission”). In alternative definition 1, an “eventful admission” was defined as receiving mechanical ventilation and/or vasopressors and/or renal replacement therapy and/or cardiopulmonary resuscitation in the first 24 h after ICU admission, or in-hospital death (as in [13]. In alternative definition 2, only receiving mechanical ventilation and/or vasopressors, or in-hospital death were included in the definition of an “eventful ICU admission” (as in [4]. ICU intervention before ICU admission was defined as receiving mechanical ventilation or cardiopulmonary resuscitation or vasopressors (over at least 1 h) before ICU admission