| CTRI Number |
CTRI/2026/01/102309 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Blood Amylase and CPK Tests to Predict Ventilator Need and Death in Patients with Organophosphorus Poisoning |
|
Scientific Title of Study
|
An Observational Study on Serum Amylase and CPK Levels as Predictors for Ventilatory Support and Mortality in Cases of OPC Poisoning |
| 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 ASWIN MANOMOHAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
J L N MEDICAL COLLEGE AJMER |
| Address |
DEPARTMENT OF EMERGENCY MEDICINE
J L N MEDICAL COLLEGE
Kala Bagh, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
8281353448 |
| Fax |
|
| Email |
aswinmanu2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KAVITA JAIN |
| Designation |
Professor and Head Of Department |
| Affiliation |
JLN MEDICAL COLLEGE AJMER |
| Address |
DEPARTMENT OF EMERGENCY MEDICINE
J L N MEDICAL COLLEGE
Kala Bagh, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmai.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr KAVITA JAIN |
| Designation |
Professor and Head Of Department |
| Affiliation |
JLN MEDICAL COLLEGE AJMER |
| Address |
DEPARTMENT OF EMERGENCY MEDICINE
J L N MEDICAL COLLEGE
Kala Bagh, Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmai.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Ajmer (JLN Medical College)
Government Medical College Campus
Ajmer, Rajasthan – 305001
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 KAVITA JAIN |
JLN MEDICAL COLLEGE AJMER |
EMERGENCY MEDICINE DEPARTMENT JLN MEDICAL COLLEGE AJMER
Ajmer
RAJASTHAN |
9414006151
drkavitajain15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,JAWAHARLAL NEHRU MEDICAL COLLEGE AJMER |
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 |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients admitted with a history of OPC compound poisoning presents within24hrs of exposure and having cholinergic toxidrome |
|
| ExclusionCriteria |
| Details |
Patient received prior treatment,have consumed multiple poisons or concurrent alcohol consumption,and patients with chronic diseases and conditions causing elevated serum amylase levels |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reqirement of mechanical ventilators support(yes/no)in Acute OPC poisoning |
During hospital stay/up to discharge or death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality |
During hospital stay/at discharge 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)
|
03/02/2026 |
| 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="0"
Months="3"
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
|
Organophosphorus compound (OPC) poisoning is a common medical emergency in India and is associated with significant morbidity and mortality. Respiratory failure is the major cause of death and many patients require ICU admission and mechanical ventilation. Early identification of patients who are likely to require ventilatory support is important for timely intervention and better resource allocation.
Serum cholinesterase is useful for diagnosis but has limitations as a prognostic marker due to variable baseline levels and inconsistent correlation with clinical severity. Serum creatine phosphokinase (CPK) and serum amylase are simple, inexpensive and widely available investigations which may reflect the severity of poisoning. CPK rises due to sustained muscle fasciculations and neuromuscular injury, while serum amylase may rise due to autonomic dysfunction and pancreatic involvement.
This hospital based prospective observational cohort study will be conducted in the Emergency Department of Jawaharlal Nehru Medical College and Associated Group of Hospitals, Ajmer, over a period of 12 months. A total of 100 adult patients with acute OPC poisoning presenting within 24 hours and having features of cholinergic toxidrome will be included after informed consent.
Serum CPK and serum amylase levels will be measured at admission before atropinization. Clinical severity will be assessed using the Peradeniya Organophosphorus Poisoning (POP) scale. Patients will be followed during hospital stay to assess requirement of mechanical ventilation and clinical outcome including mortality and duration of ICU stay.
The study aims to evaluate serum CPK and serum amylase as prognostic biomarkers for ventilatory support and mortality in OPC poisoning and to assess their correlation with severity of poisoning. |