Drug ToxicityNCT04987801
Evaluation of Drug Overdose Poisoning Cases and Indications for ICU Admission
An observational study of Drug Toxicity, run by Assiut University at 1 site in Egypt.
Trial summary
1. Evaluation of drug overdose cases presented to Assiut university hospitals' adults and pediatric emergency departments (EDs) in one year period. 2. Evaluation the role of intensive care unit (ICU) admission in these cases and possible scoring system for common groups of drug overdose. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Toxicity
- What is being tested?
- Drug Toxicity
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 31 Mar 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who took over dose of Drugs
Who may be able to join
- Patients admitted or transferred to Assiut university hospitals' adults and pediatric EDs, with history of drug overdose intoxication within 24 hours prior to admission (single or multiple drug ingestions).
- Patients admitted or transferred to Assiut university hospitals' adults and pediatric EDs, with clinical signs and symptoms of drug overdose intoxication on examination.
- Patients admitted or transferred to Assiut university hospitals' adults and pediatric EDs, with blood and/or urine toxicology screens demonstrated the presence of non-prescribed, illicit drugs or inappropriately elevated levels of prescribed or over the-counter medications.
Who cannot join
- Patients admitted or transferred to Assiut university hospitals' adults and pediatric EDs, with history of drug overdose intoxication more than 24 hours.
- Patients admitted or transferred to Assiut university hospitals' adults and pediatric EDs, with history of non-drug intoxication, e.g insecticides poisoning
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine
Asyut
Peter Eissa Saad, 01276086545, petereissa3@gmail.com
About this study
- Evaluation of drug overdose cases presented to Assiut university hospitals' adults and pediatric emergency departments (EDs) in one year period.
- Evaluation the role of intensive care unit (ICU) admission in these cases and possible scoring system for common groups of drug overdose.
Read the detailed description
Poisoning is a medical emergency representing a health problem all over the world with an incidence rate that is variable from one place to another.
The nature of poison used varies in different parts of the world and may vary even in different parts of the same country.
The pattern of poisoning within a country depends on several factors such as the accessibility of various poisons, socio-economic status of the population, religious and cultural influences and drug prescription manners.
Drug overdose continues to be the most common cause of acute poisoning all over the world. An estimated 2 to 5 million poisonings and drug overdoses occur annually in the United States of America.
Overdose is the most common manifestation of deliberate self-harm behavior, and is a common cause of presentation to hospital Emergency Departments (EDs). It starts to get global attention due to its higher rate of morbidity and mortality in spite of being a preventable cause of death.
Acute drug overdosing is an important cause of organ dysfunction and metabolic derangements and the patients often require intensive care admission. Among patients admitted to hospital following drug overdoses, approximately 13-22% will require Intensive Care Unit (ICU) admission. Overdoses have been reported to account for 3.8-13.8% of all ICU admissions with 79.5-84% requiring mechanical ventilation in Australia.
The treatment and complications of patients with acute drug intoxication in ICU vary according the nature of the substance ingested, individual amount of drug, and the concomitant use of other substances. The interventions requiring critical care in acute drug-poisoned patients include the need for airways protection and mechanical ventilation, hemodynamic stabilization and needs for vasopressors, and specific procedures that would enhance the clearance of the toxins involved.
- Conditions
- Drug Toxicity
- Being tested
- Drug Toxicity
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug ToxicityOther
Patients who took over dose of Drugs
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of drug overdose cases presented to Assiut university hospitals' adults and pediatric E.D.
- Sheet includes the following items:-
- Demographic data: Gender, Age, Marital status, Residence, Occupation, Special habits: smoking, drug abuse.
- Data regarding overdosed drug: Type, form, dose and method of administration and mode of exposure
- Symptoms of intoxication. B) Complete clinical examination
- Investigations:
- Routine: ABG, ECG, Electrolytes
- Specific Drug level, drug screening test in urine
Measured: One year
Secondary outcomes (1)
Evaluation of the indications of intensive care unit (ICU) admission in drug overdose cases.
Evaluation the role of intensive care unit (ICU) admission in drug overdose cases and possible scoring system for common groups of drug overdose:
Patients admitted to ICU will be monitored regarding:
- Criteria of admission: acid base disturbance, altered conscious level, organ failure, etc.
- Intervention methods: mechanical ventilation, inotropes, dialysis, etc.
- Period of ICU Admission.
- Fate : complete recovery, complications, death
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Apr 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Drug ToxicityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Eissa Saad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987801
- Sponsor's protocol ID
- Drug overdose Evaluation
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Athavale V, Green C, Lim KZ, Wong C, Tiruvoipati R. Characteristics and outcomes of patients with drug overdose requiring admission to Intensive Care Unit. Australas Psychiatry. 2017 Oct;25(5):489-493. doi: 10.1177/1039856217706824. Epub 2017 Jul 13.
PubMed 28703691Bakhaidar M, Jan S, Farahat F, Attar A, Alsaywid B, Abuznadah W. Pattern of drug overdose and chemical poisoning among patients attending an emergency department, western Saudi Arabia. J Community Health. 2015 Feb;40(1):57-61. doi: 10.1007/s10900-014-9895-x.
PubMed 24927975Jayakrishnan B, Al Asmi A, Al Qassabi A, Nandhagopal R, Mohammed I. Acute drug overdose: clinical profile, etiologic spectrum and determinants of duration of intensive medical treatment. Oman Med J. 2012 Nov;27(6):501-4. doi: 10.5001/omj.2012.120.
PubMed 23226824Savage M, Kung R, Green C, Thia B, Perera D, Tiruvoipati R. Predictors of ICU admission and long-term outcomes in overdose presentations to Emergency Department. Australas Psychiatry. 2020 Feb;28(1):75-79. doi: 10.1177/1039856219889317. Epub 2020 Jan 8.
PubMed 31912753Tawfik, H., & Khalifa, E. (2017). Evaluation of Poisoning and Drug Overdose among Cases Presented to Poison Control Centre, Ain Shams University Hospital during the Year 2015. Ain Shams Journal of Forensic Medicine and Clinical Toxicology, 29(2), 100-112.
Zhao M, Ji XP, Wang NN, Liu SY, Wang YZ. Study of poisoning pattern at China Medical University from 1997 to 2007. Public Health. 2009 Jun;123(6):454-5. doi: 10.1016/j.puhe.2009.04.010. Epub 2009 Jun 3. No abstract available.
PubMed 19497600Cioccari L, Luethi N, Bailey M, Pilcher D, Bellomo R. Characteristics and outcomes of critically ill patients with drug overdose in Australia and New Zealand. Crit Care Resusc. 2017 Mar;19(1):14-22.
PubMed 28215127Orsini, Jose, et al.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Drug Overdose Poisoning Cases and Indications for ICU Admission
- ClinicalTrials.gov ID
- NCT04987801
- Acronym / sponsor ID
- Drug overdose Evaluation
- Conditions
- Drug Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 3 Aug 2021 (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.
- Evaluation of drug overdose cases presented to Assiut university hospitals' adults and pediatric emergency departments (EDs) in one year period.
- Evaluation the role of intensive care unit (ICU) admission in these cases and possible scoring system for common groups of drug overdose.
Detailed description
Poisoning is a medical emergency representing a health problem all over the world with an incidence rate that is variable from one place to another.
The nature of poison used varies in different parts of the world and may vary even in different parts of the same country.
The pattern of poisoning within a country depends on several factors such as the accessibility of various poisons, socio-economic status of the population, religious and cultural influences and drug prescription manners.
Drug overdose continues to be the most common cause of acute poisoning all over the world. An estimated 2 to 5 million poisonings and drug overdoses occur annually in the United States of America.
Overdose is the most common manifestation of deliberate self-harm behavior, and is a common cause of presentation to hospital Emergency Departments (EDs). It starts to get global attention due to its higher rate of morbidity and mortality in spite of being a preventable cause of death.
Acute drug overdosing is an important cause of organ dysfunction and metabolic derangements and the patients often require intensive care admission. Among patients admitted to hospital following drug overdoses, approximately 13-22% will require Intensive Care Unit (ICU) admission. Overdoses have been reported to account for 3.8-13.8% of all ICU admissions with 79.5-84% requiring mechanical ventilation in Australia.
The treatment and complications of patients with acute drug intoxication in ICU vary according the nature of the substance ingested, individual amount of drug, and the concomitant use of other substances. The interventions requiring critical care in acute drug-poisoned patients include the need for airways protection and mechanical ventilation, hemodynamic stabilization and needs for vasopressors, and specific procedures that would enhance the clearance of the toxins involved.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who took over dose of Drugs
Key inclusion criteria (3 listed)
- Patients admitted or transferred to Assiut university hospitals' adults and pediatric EDs, with history of drug overdose intoxication within 24 hours prior to admission (single or multiple drug ingestions).
- Patients admitted or transferred to Assiut university hospitals' adults and pediatric EDs, with clinical signs and symptoms of drug overdose intoxication on examination.
- Patients admitted or transferred to Assiut university hospitals' adults and pediatric EDs, with blood and/or urine toxicology screens demonstrated the presence of non-prescribed, illicit drugs or inappropriately elevated levels of prescribed or over the-counter medications.
Key exclusion criteria (2 listed)
- Patients admitted or transferred to Assiut university hospitals' adults and pediatric EDs, with history of drug overdose intoxication more than 24 hours.
- Patients admitted or transferred to Assiut university hospitals' adults and pediatric EDs, with history of non-drug intoxication, e.g insecticides poisoning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug ToxicityPatients who took over dose of Drugs | Other | – |
Primary outcome
Evaluation of drug overdose cases presented to Assiut university hospitals' adults and pediatric E.D.
Time frame: One year
A) Sheet includes the following items:- 1. Demographic data: Gender, Age, Marital status, Residence, Occupation, Special habits: smoking, drug abuse. 2. Data regarding overdosed drug: Type, form, dose and method of administration and mode of exposure 3. Symptoms of intoxication. B) Complete clinical examination C) Investigations: 1. Routine: ABG, ECG, Electrolytes 2. Specific Drug level, drug screening test in urine
1 secondary outcome
Evaluation of the indications of intensive care unit (ICU) admission in drug overdose cases.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 28703691Athavale V, Green C, Lim KZ, Wong C, Tiruvoipati R. Characteristics and outcomes of patients with drug overdose requiring admission to Intensive Care Unit. Australas Psychiatry. 2017 Oct;25(5):489-493. doi: 10.1177/1039856217706824. Epub 2017 Jul 13.
- Background: PubMed 24927975Bakhaidar M, Jan S, Farahat F, Attar A, Alsaywid B, Abuznadah W. Pattern of drug overdose and chemical poisoning among patients attending an emergency department, western Saudi Arabia. J Community Health. 2015 Feb;40(1):57-61. doi: 10.1007/s10900-014-9895-x.
- Background: PubMed 23226824Jayakrishnan B, Al Asmi A, Al Qassabi A, Nandhagopal R, Mohammed I. Acute drug overdose: clinical profile, etiologic spectrum and determinants of duration of intensive medical treatment. Oman Med J. 2012 Nov;27(6):501-4. doi: 10.5001/omj.2012.120.
- Background: PubMed 31912753Savage M, Kung R, Green C, Thia B, Perera D, Tiruvoipati R. Predictors of ICU admission and long-term outcomes in overdose presentations to Emergency Department. Australas Psychiatry. 2020 Feb;28(1):75-79. doi: 10.1177/1039856219889317. Epub 2020 Jan 8.
- BackgroundTawfik, H., & Khalifa, E. (2017). Evaluation of Poisoning and Drug Overdose among Cases Presented to Poison Control Centre, Ain Shams University Hospital during the Year 2015. Ain Shams Journal of Forensic Medicine and Clinical Toxicology, 29(2), 100-112.
- Background: PubMed 19497600Zhao M, Ji XP, Wang NN, Liu SY, Wang YZ. Study of poisoning pattern at China Medical University from 1997 to 2007. Public Health. 2009 Jun;123(6):454-5. doi: 10.1016/j.puhe.2009.04.010. Epub 2009 Jun 3. No abstract available.
- Background: PubMed 28215127Cioccari L, Luethi N, Bailey M, Pilcher D, Bellomo R. Characteristics and outcomes of critically ill patients with drug overdose in Australia and New Zealand. Crit Care Resusc. 2017 Mar;19(1):14-22.
- BackgroundOrsini, Jose, et al.
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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.
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 Drug Toxicity, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Aug 2021. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Eissa Saad (01276086545, Petereissa3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of drug overdose cases presented to Assiut university hospitals' adults and pediatric E.D. (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04987801, which also lists 8 linked publications.
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 3 Aug 2021.