| CTRI Number |
CTRI/2024/07/071482 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to find relation of symptoms and lab tests with severity of Insecticide/Pesticide poisoning |
|
Scientific Title of Study
|
To study clinical and biochemical parameters in predicting the severity of OP poisoning patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divyam Suri |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine ,Kasturba Medical College, Madhav Nagar , Manipal
Manipal Academy of Higher Education , Madhav Nagar , Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8510826885 |
| Fax |
|
| Email |
divyam.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Bhat |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine ,Kasturba Medical College, Madhav Nagar , Manipal
Manipal Academy of Higher Education , Madhav Nagar , Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945272251 |
| Fax |
|
| Email |
ram.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ram Bhat |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Medicine ,Kasturba Medical College, Madhav Nagar , Manipal
Manipal Academy of Higher Education , Madhav Nagar , Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945272251 |
| Fax |
|
| Email |
ram.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine ,Kasturba Medical College, Madhav Nagar , Manipal, Karnataka, 576104
India |
|
|
Primary Sponsor
|
| Name |
Department of General Medicine |
| Address |
Kasturba Medical College, Madhav Nagar , Manipal, Karnataka, 576104
India |
| Type of Sponsor |
Private 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 Divyam Suri |
Kasturba Hospital, Manipal |
Department of General Medicine ,Kasturba Hospital, Madhav Nagar, Manipal, Karnataka 576104
India
Udupi
KARNATAKA |
08510826885
divyam.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T440||Poisoning by, adverse effect of and underdosing of anticholinesterase agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All cases of organophosphorus poisoning within 48 hours of poisoning, confirmed by history, circumstantial evidence of poisoning, specific clinical examination, and basic laboratory reports |
|
| ExclusionCriteria |
| Details |
1. Patients with a history of intake of organophosphorus compound mixed with any other poison or alcohol.
2. Patients having chronic alcohol intake.
3. Patients who are a known case of chronic liver disease.
4. Patients with chronic renal failure or any other renal disorders.
5. Patients with chronic pancreatitis of any etiology.
6. Patients with diseases of the salivary gland.
7. Pregnant females.
8. Patients with malignancy or metastasis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of clinical profile, serum amylase, lipase, plasma cholinesterase, and creatine phosphokinase with severity of organophosphorus poisoning |
Prospective observational study
Outcome to be assessed at baseline and at 5 days of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Study of outcome concerning the time interval between poisoning & initiation of treatment
2. Significance of QT interval as a prognostic factor in organophosphorus poisoning |
Prospective observational study
Outcome to be assessed at baseline & at 5 days of admission |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/08/2024 |
| Date of Study Completion (India) |
14/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study will recruit all cases that are 18 years and older of organophosphorus poisoning within 48 hours of poisoning, confirmed by history, circumstantial evidence of poisoning, specific clinical examination, and basic laboratory reports. Patients with mixed poisoning, chronic liver disease, chronic kidney disease, chronic pancreatitis, chronic alcohol intake, pregnancy, and patients with malignancy or metastasis will be excluded from the study.
Objectives of the study - 1. To study the clinical profile and its correlation with biomarkers in organophosphorus poisoning. 2. To study the correlation of serum amylase, lipase, creatine phosphokinase, and plasma cholinesterase with organophosphorus poisoning outcome. 3. To study association between time intervalfrom poisoning to intervention ( atropine administeration and gastric lavage ) with the outcome in OP poisoning . 4. To study the significance of QT interval as a prognostic factor in acute organophosphorus poisoning.
Clinical data and the lab parameters done during admission and ECG changes will be documented in a data proforma. Consent will be taken from the patient after explaining to him/her the nature of the study. However, if the patient is not in a condition to give consent, the consent would be obtained from next of kin, either spouse,parent, or guardian . All the patients admitted to the Kasturba Hospital with organophosphorus poisoning will be followed for the clinical outcome. only one admission of the patient during the study period will be considered. Clinical outcomes will be assessed by Duration of hospitalization in days, requirement and duration of mechanical ventilation, and whether survived or expired. Peradeniya Organophosphorus poisoning scale will be used for grading of poisoning of the patients. Microsoft Excel sheet will be used for compilation and SPSS software will be used for statistical analysis. As this study is purely observational, patient management will be chosen by patient-physician without any intervention from the study investigators. The duration of the study is expected to be 2 years.
|