| CTRI Number |
CTRI/2024/03/063529 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of symptoms, laboratory reports, treatment and survival of patients who have herbicide poisoning |
|
Scientific Title of Study
|
To explore the clinical, demographic profile and outcomes of patients presenting with herbicide poisoning in a tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramamoorthi |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Department of General Medicine, KMC Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7892762140 |
| Fax |
|
| Email |
ramamoorthi.k@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramamoorthi |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Department of General Medicine, KMC Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
7892762140 |
| Fax |
|
| Email |
ramamoorthi.k@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarath Maruthampadath |
| Designation |
Postgraduate |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Department of General Medicine, KMC Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9110281644 |
| Fax |
|
| Email |
sarathmenon37@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine,
Kasturba Medical College Manipal, Madhav Nagar, Manipal, Udupi, Karnataka
576104 |
|
|
Primary Sponsor
|
| Name |
Sarath Maruthampadath |
| Address |
Department of General Medicine, Kasturba Medical College Manipal, Madhav Nagar, Manipal, Udupi, Karnataka 576104 |
| 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 |
| Dr Ramamoorthi |
Kasturba Hospital,Manipal |
Intensive Care Unit 1 and 2, 1st floor, emergency block, Kasturba Medical College Manipal, Madhav Nagar, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA |
7892762140
ramamoorthi.k@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-2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T658||Toxic effect of other specified substances, |
|
|
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 patients of age more than 18 years with history of herbicide consumption admitted in Kasturba Hospital, Manipal |
|
| ExclusionCriteria |
| Details |
Patients who consumed the poisons other than herbicides. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Survival (Survived/Dead) |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Length of hospital stay |
End of Hospital Stay(Discharge/Death) |
| Requirement of Mechanical Ventilator |
End of Hospital Stay(Discharge/Death) |
| Requirement of Vasopressors |
End of Hospital Stay(Discharge/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)
|
11/03/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Our study title is To explore the clinical, demographic profile and outcomes of patients presenting with herbicide poisoning in a tertiary care hospital. The objectives of the study include to study the clinico-demographic profile and outcome of patients presenting with herbicide poisoning to a tertiary care hospital, to determine the factors affecting outcome (ventilator requirement, length of ICU stay, vasopressor requirement, mortality) in patients presenting with paraquat consumption, To determine the factors affecting outcome (ventilator requirement, length of ICU stay, vasopressor requirement, mortality) in patients presenting with glyphosate consumption. We will also compare scoring systems (SOFA, APACHE II, SAPS III) in predicting mortality in patients with herbicide poisoning. We will also determine the accuracy of ultrasound based composite score (Lung Ultrasound, Renal Resistive Index, Respiratory Rate) to predict 48hrs mortality in paraquat poisoning. Approval from Institutional ethics and CTRI will be taken. After the approval, patients will be enrolled as per inclusion and exclusion criteria mentioned earlier. An information sheet containing the details of the study will be given and the subjects will be explained about the objectives of the study. Informed consent will be taken from the subjects. Both information sheet and informed consent will be made available in English as well as in Kannada. Demographic details, clinical history, general and systemic examination findings will be noted. Laboratory investigations which are sent as per treating physician will be recorded in a predesigned proforma. Ultrasound findings performed by the emergency physician/ critical care physician will be noted for the lung ultrasound score and renal resistive index. Treatment done during the course of hospital stay will be noted. 48hour mortality will be recorded. Patient outcomes will be noted- discharge/death/discharged against advice, length of hospital stays, requirement of ventilator, vasopressors and need for hemodialysis/hemoperfusion. The collected data will undergo statistical analysis. |