| CTRI Number |
CTRI/2021/09/036691 [Registered on: 21/09/2021] Trial Registered Prospectively |
| Last Modified On: |
30/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of patients admit in emergency with poisoning |
|
Scientific Title of Study
|
CLINICO-EPIDEMIOLOGICAL PROFILE AND OUTCOME OF PATIENTS WITH ACUTE POISONING PATIENTS PRESENTING TO EMERGENCY OF A TERTIARY CARE CENTRE IN WESTERN RAJASTHAN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AKHIL V GEORGE |
| Designation |
JR Academics Emergency Medicine AIIMS Jodhpur |
| Affiliation |
AIIMS JODHPUR |
| Address |
AIIMS JODHPUR
BASNI PH 2
RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
919633495444 |
| Fax |
|
| Email |
akhilvgeorgeklh123@gmail.xom |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANKUR SHARMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS JODHPUR |
| Address |
AIIMS JODHPUR
BASNI PH 2
RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
919654045653 |
| Fax |
|
| Email |
ankuranaesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANKUR SHARMA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
AIIMS JODHPUR |
| Address |
AIIMS JODHPUR
BASNI PH 2
RAJASTHAN
Jodhpur
RAJASTHAN
342005
India |
| Phone |
919654045653 |
| Fax |
|
| Email |
ankuranaesthesia@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS JODHPUR |
| Address |
BASNI PH2
AIIMS JODHPUR
342008 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DR ANKUR SHARMA |
All India Institute of medical sciences, Jodhpur |
Emergency block
BASNI Phase 2
JODHPUR 342005
Jodhpur
RAJASTHAN |
919654045653
ankuranaesthesia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T659||Toxic effect of unspecified substance, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Month(s) |
| Age To |
99.99 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex belonging to any age group with acute poisoning attending the emergency |
|
| ExclusionCriteria |
| Details |
Patients with idiosyncratic or adverse reaction to prescribed drug
Food poisoning
Snake /unknown bites
Patients or relatives refusing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the clinico-epidemological profile of patients with acute poisoning presenting to the emergency |
At the time of presentation in emergency |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome of patients with acute poisoning presenting the emergency |
Till discharge from hospital or death |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study will be conducted to study clinico-epidemiological profile and outcomes of patients with acute poisoning presenting in the emergency department. Data regarding age, sex, socio-economic class, , marital status, type of poison and suggested clinical features will be collected . A complete history, physical, local, and clinical examination, GCS, SOFA will be recorded. Patients will be followed till discharge from hospital or till death. |