| CTRI Number |
CTRI/2023/05/053036 [Registered on: 22/05/2023] Trial Registered Prospectively |
| Last Modified On: |
14/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Pesticide poisoning cases: A study on outcomes |
|
Scientific Title of Study
|
Organophosphorus poisoning:A retrospective study on clinical profiles and outcomes in ICU |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nadia Rose |
| Designation |
Associate Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology
Rajarajeswari Medical college and Hospital
Bangalore,Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
|
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nadia Rose |
| Designation |
Associate Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology
Rajarajeswari Medical college and Hospital
Bangalore,Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
|
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nadia Rose |
| Designation |
Associate Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology
Rajarajeswari Medical college and Hospital
Bangalore,Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
|
| Fax |
|
| Email |
dr.nadia.rose@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Medical college and hospital,bangalore,karnataka-560074 |
|
|
Primary Sponsor
|
| Name |
Nadia Rose |
| Address |
Department of Anaesthesiology,rajarajeswari Medical college and hospital,Bangalore,karnataka-560074 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nadia Rose |
Rajarajeswari Medical college and hospital. |
Medical records department.
Bangalore
KARNATAKA |
9513454567
dr.nadia.rose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari medical college and hospital instituitional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T600||Toxic effect of organophosphate and carbamate insecticides, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All Patients with age more than or equal to 18 years admitted to ICU
with history of acute organophosphorus poisoning. |
|
| ExclusionCriteria |
| Details |
1.Incomplete case records
2.Concurrent ingestion of another poisonous substance |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To explore the epidemiological characteristics and clinical profile of patients admitted to ICU with OP
poisoning |
Admission to discharge or death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the outcomes including complications, inhospital mortality, and the predictors of
mortality |
Admission to discharge or death |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2023 |
| Date of Study Completion (India) |
29/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Organophosphorus compounds are widely used in India as insecticides and is the culprit in many suicidal poisoning cases reported in the country.Acetylcholinesterase inhibition by organophosphorus pesticides or organophosphate nerve agents can cause acute parasympathetic system dysfunction, muscle weakness, seizures, coma, and respiratory failure. Prognosis depends on the dose and relative toxicity of the specific compound, as well as pharmacokinetic factors. A literature search was conducted and the search revealed that only a few studies have considered the clinical profile and outcomes of organophosphorus poisoning patients admitted in the intensive care unit. |