- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04987801
Evaluation of Drug Overdose Poisoning Cases and Indications for ICU Admission
- 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.
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Peter Eissa Saad
- Phone Number: 01276086545
- Email: petereissa3@gmail.com
Study Locations
-
-
-
Assiut, Egypt
- Recruiting
- Faculty of medicine
-
Contact:
- Peter Eissa Saad
- Phone Number: 01276086545
- Email: petereissa3@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:-
C) Investigations:
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the indications of intensive care unit (ICU) admission in drug overdose cases.
Time Frame: one year
|
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:
|
one year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Bakhaidar 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.
- Jayakrishnan 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.
- Savage 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.
- Tawfik, 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.
- Cioccari 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.
- Orsini, Jose, et al.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Drug overdose Evaluation
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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