Evaluation of Drug Overdose Poisoning Cases and Indications for ICU Admission

Drug Toxicity Clinical Trial

Official title:

Evaluation of Drug Overdose Poisoning Cases and Indications for ICU Admission

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987801
• Other study ID #: Drug overdose Evaluation
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2021
• Source: Assiut University
• Contact: Peter Eissa Saad
• Phone: 01276086545
• Email: Petereissa3[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions
• Poisoning

Intervention

Other:
• Drug Toxicity
Patients who took over dose of Drugs

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Orsini, Jose, et al.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of drug overdose cases presented to Assiut university hospitals' adults and pediatric E.D.	A) 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; C) Investigations: Routine: ABG, ECG, Electrolytes; Specific Drug level, drug screening test in urine	One year
Secondary	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	one year