Intoxication, DepthNCT05933421
A Single Center Retrospective Cohort Study of Auto-intoxicated Patients Admitted to the ICU
An observational study of Intoxication, Depth, run by Jessa Hospital at 1 site in Belgium.
Trial summary
Intentional poisoning is a relevant public health issue responsible for a considerable number of cases of morbidity and mortality worldwide. There are no concrete numbers/investigations of these patients admitted to the ICU at our hospital, with limited insight on their characteristics and outcome. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Intoxication, Depth
- How many people
- 377 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Jul 2023to 15 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients (>14 years of age) diagnosed with self-poisoning and admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022 were included in the study.
Who may be able to join
- All patients (>14 years of age) diagnosed with self-poisoning and admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022 were included in the study.
Who cannot join
- Patient admitted for tentamen suicide but not due to intoxication were excluded as well as patients with no medical records in the Jessa hospital.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Retrospective Cohort Study of Auto-intoxicated Patients Admitted to the ICU: Descriptive Analysis
Intentional poisoning is a relevant public health issue responsible for a considerable number of cases of morbidity and mortality worldwide. There are no concrete numbers/investigations of these patients admitted to the ICU at our hospital, with limited insight on their characteristics and outcome.
It is expected that this population of patients is an important burden for the ICU. It can be important to shed a light on prevalence and ratio of intoxicated patients admitted to the ICU in our center.
Furthermore, during the covid-pandemic, we could expect an increase in self-poisoning prevalence due to social restrictions, more limited access to (mental) health care, etc…
Read the detailed description
Aim The aims of this study are to quantify the ratio of intensive care admissions attributable to self-poisoning in our hospital, to examine characteristics and outcome of these patients, yearly trends and impact of the covid-pandemic on these variables.
Design A single center retrospective cohort study analysis of patients with self-poisoning admitted to ICU of the Jessa Hospital Hasselt Belgium over a period of 6 years (2017-2022).
Sample size
All patients diagnosed with self-poisoning admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022 were included in the study. This were 377 patients.
Study population
Inclusion and exclusion criteria:
All patients (>14 years of age) diagnosed with self-poisoning and admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022 were included in the study.
Patient admitted for tentamen suicide but not due to intoxication were excluded as well as patients with no medical records in the Jessa hospital.
Primary Outcome The prevalence of auto-intoxicated patients admitted to the ICU together with the mortality rate on the ICU.
Secondary Outcome measurements
Secondary outcome measurement are the ICU and hospital length of stay, ratio of auto-intoxicated patients to all patients admitted at ICU, types of drugs ingested, number of drugs involved, cause of admission, yearly trends and impact of covid-pandemic.
Statistical analysis Data will be presented as mean values +/-SD, numbers(n), and percentages(%) or median (25%, 75% percentile) in case of non-parametric data. Categorical variables are presented as frequencies (%) and groups were compared using Chi-square or Fisher's exact test.
Differences between patients change will be analyzed using the Student t test for continuous outcomes or, in case of non-parametric data, the Mann-Whitney U test. Univariate and multivariate logistic regression models will be used in order to predict mortality. P values <0.05 will be considered statistically significant.
Additional data collection:
Additional collected parameters are listed below and are collected as a standard-of-care in our hospital:
- Demographics: i.e age, gender, BMI
- DNR-code
- Admission route
- Patient state and symptoms: i.e vital signs, GCS, …
- Comorbidities: i.e smoking, obesity, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure, liver failure, neurological conditions, mental state and disease
- Technical investigation results: i.e Laboratory results, ECG, radiological findings, etc…
- Complications: i.e shock, heart failure, sepsis, stroke, etc…
- Ventilation: method, PEEP, FiO2, P/F ratio,…
- Management: i.e antidote, supportive, mechanical ventilation, dialysis, observation,
- Conditions
- Intoxication, Depth
- Medical subject headings
- Inert Gas Narcosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of mortality
The prevalence of auto-intoxicated patients admitted to the ICU together with the mortality rate on the ICU.
Measured: patient admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
Secondary outcomes (7)
ICU length of stay
Length of stay in the ICU
Measured: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
hospital length of stay
Length of stay in the hospital
Measured: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
Relative number of auto-intoxicated patients at ICU
ratio of auto-intoxicated patients to all patients admitted at ICU,
Measured: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
Type
type of drugs ingested by patients admitted to ICU
Measured: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
number of drugs or medication
number of drugs or medication ingested by patients admitted to ICU
Measured: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
Cause
cause of admission to ICU: emotional, relational, somatic, psychological, financial, workrelated, recreative, other or unknown
Measured: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
Impact of COVID-19 pandemic
the impact of the COVID-19 pandemic on the number of auto-intoxicated patients admitted to ICU
Measured: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start3 Jul 2023
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intoxication, DepthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933421
- Sponsor's protocol ID
- f/2023/041
- Status last verified
- Sep 2023
- First submitted
- 28 Jun 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Retrospective Cohort Study of Auto-intoxicated Patients Admitted to the ICU: Descriptive Analysis
- ClinicalTrials.gov ID
- NCT05933421
- Acronym / sponsor ID
- f/2023/041
- Conditions
- Intoxication, Depth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 377 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intentional poisoning is a relevant public health issue responsible for a considerable number of cases of morbidity and mortality worldwide. There are no concrete numbers/investigations of these patients admitted to the ICU at our hospital, with limited insight on their characteristics and outcome.
It is expected that this population of patients is an important burden for the ICU. It can be important to shed a light on prevalence and ratio of intoxicated patients admitted to the ICU in our center.
Furthermore, during the covid-pandemic, we could expect an increase in self-poisoning prevalence due to social restrictions, more limited access to (mental) health care, etc…
Detailed description
Aim The aims of this study are to quantify the ratio of intensive care admissions attributable to self-poisoning in our hospital, to examine characteristics and outcome of these patients, yearly trends and impact of the covid-pandemic on these variables.
Design A single center retrospective cohort study analysis of patients with self-poisoning admitted to ICU of the Jessa Hospital Hasselt Belgium over a period of 6 years (2017-2022).
Sample size
All patients diagnosed with self-poisoning admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022 were included in the study. This were 377 patients.
Study population
Inclusion and exclusion criteria:
All patients (>14 years of age) diagnosed with self-poisoning and admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022 were included in the study.
Patient admitted for tentamen suicide but not due to intoxication were excluded as well as patients with no medical records in the Jessa hospital.
Primary Outcome The prevalence of auto-intoxicated patients admitted to the ICU together with the mortality rate on the ICU.
Secondary Outcome measurements
Secondary outcome measurement are the ICU and hospital length of stay, ratio of auto-intoxicated patients to all patients admitted at ICU, types of drugs ingested, number of drugs involved, cause of admission, yearly trends and impact of covid-pandemic.
Statistical analysis Data will be presented as mean values +/-SD, numbers(n), and percentages(%) or median (25%, 75% percentile) in case of non-parametric data. Categorical variables are presented as frequencies (%) and groups were compared using Chi-square or Fisher's exact test.
Differences between patients change will be analyzed using the Student t test for continuous outcomes or, in case of non-parametric data, the Mann-Whitney U test. Univariate and multivariate logistic regression models will be used in order to predict mortality. P values <0.05 will be considered statistically significant.
Additional data collection:
Additional collected parameters are listed below and are collected as a standard-of-care in our hospital:
- Demographics: i.e age, gender, BMI
- DNR-code
- Admission route
- Patient state and symptoms: i.e vital signs, GCS, …
- Comorbidities: i.e smoking, obesity, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure, liver failure, neurological conditions, mental state and disease
- Technical investigation results: i.e Laboratory results, ECG, radiological findings, etc…
- Complications: i.e shock, heart failure, sepsis, stroke, etc…
- Ventilation: method, PEEP, FiO2, P/F ratio,…
- Management: i.e antidote, supportive, mechanical ventilation, dialysis, observation,
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients (>14 years of age) diagnosed with self-poisoning and admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022 were included in the study.
Key inclusion criteria (1 listed)
- All patients (>14 years of age) diagnosed with self-poisoning and admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022 were included in the study.
Key exclusion criteria (1 listed)
- Patient admitted for tentamen suicide but not due to intoxication were excluded as well as patients with no medical records in the Jessa hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of mortality
Time frame: patient admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
The prevalence of auto-intoxicated patients admitted to the ICU together with the mortality rate on the ICU.
7 secondary outcomes
ICU length of stay
Time frame: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
hospital length of stay
Time frame: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
Relative number of auto-intoxicated patients at ICU
Time frame: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
Type
Time frame: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
number of drugs or medication
Time frame: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
Cause
Time frame: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
Impact of COVID-19 pandemic
Time frame: patients admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intoxication, Depth, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of mortality (time frame: patient admitted to the ICU of the Jessa hospital between 01/01/2017 and 31/12/2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023; AzTrials last refreshed its copy on 7 Nov 2026.