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Status unknownNCT04987801Updated Aug 3, 2021

Evaluation of Drug Overdose Poisoning Cases and Indications for ICU Admission

An observational study in Drug Toxicity, sponsored by Assiut University. Status unknown at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2021-08-03.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study 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 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.

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Conditions studied

03

In context

Drug Overdose

139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.

This study's planned enrollment of 100 is below the median of 175 across 38 observational studies indexed under Drug Overdose.

Browse Drug Overdose studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who took over dose of Drugs

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Interventions

  • OtherDrug Toxicity

    Patients who took over dose of Drugs

06

What researchers measure

Primary outcomes

  1. Evaluation of drug overdose cases presented to Assiut university hospitals' adults and pediatric E.D.

    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

    Time frame: 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

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Faculty of medicine
    Assiut, Egypt
    Recruiting
08

References and documents

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 28703691 ↗
  • 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. PubMed 24927975 ↗
  • 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. PubMed 23226824 ↗
  • 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. PubMed 31912753 ↗
  • 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. PubMed 19497600 ↗
  • 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. PubMed 28215127 ↗
  • Orsini, Jose, et al.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04987801
Lead sponsor
Assiut University
Responsible party
Peter Eissa Saad (Demonstrator at Forensic and clinical toxicology department, Assiut University) — Principal investigator
First posted
Aug 3, 2021
Start date
Apr 1, 2021
Primary completion
Mar 31, 2022 (estimated)
Completion
Mar 31, 2022 (estimated)
Last update
Aug 3, 2021

Study contacts

Peter Eissa Saad
Contact
Petereissa3@gmail.com
01276086545

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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