| CTRI Number |
CTRI/2020/12/030089 [Registered on: 29/12/2020] Trial Registered Prospectively |
| Last Modified On: |
28/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case series study |
| Study Design |
Other |
|
Public Title of Study
|
C-reactive protein and Red cell
distribution width in the assessment of severity and out come of organophosphorus poisoning |
|
Scientific Title of Study
|
C-reactive protein and Red cell distribution width as a prognostic marker for outcome of Organophosphorus poisoning |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRGSREENATH |
| Designation |
junior resident |
| Affiliation |
S.Nijalingappa medical college and Hangal shri kumareshwara hospital |
| Address |
Department of General Medicine, S.Nijalingappa Medical college and Hangal shri kumareshwara hospital,navanagar,Bagalkot,
Karnataka,India.
Bagalkot
KARNATAKA
587102
India |
| Phone |
9611264888 |
| Fax |
|
| Email |
sreenath344@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRKRUTIKA MORAPPANAVAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
S.Nijalingappa medical college and Hangal shri kumareshwara hospital |
| Address |
Department of General Medicine, S.Nijalingappa medical college and Hangal shri kumareshwara hospital,navanagar,Bagalkot,
Karnataka,India.
Bagalkot
KARNATAKA
587102
India |
| Phone |
9164504415 |
| Fax |
|
| Email |
drkrutika14488@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KRUTIKA MORAPPANAVAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
S.Nijalingappa medical college and Hangal shri kumareshwara hospital |
| Address |
Department of General Medicine ,S.Nijalingappa medical college and Hangal shri kumareshwara hospital,navanagar,Bagalkot,
Karnataka,India.
Bagalkot
KARNATAKA
587102
India |
| Phone |
9164504415 |
| Fax |
|
| Email |
drkrutika14488@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.Nijalingappa medical college and Hangal shri kumareshwara hospital,navanagar,Bagalkot,
Karnataka,India. |
|
|
Primary Sponsor
|
| Name |
SNMC HSK HOSPITAL BAGALKOT |
| Address |
S.Nijalingappa medical college and
Hangal shri kumareshwara hospital,navanagar,Bagalkot,
Karnataka,India.
Bagalkot
KARNATAKA
587102
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 |
| DRGSreenath |
S.Nijalingappa medical college and Hangal shri kumareshwara hospital |
Department of general
medicine.
Bagalkot
KARNATAKA |
9611264888
sreenath344@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| instituional ethical comite |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged more than 18 years who are admitted with acute organophosphorus poisoning within 24 hours with clinical features and physical evidence of consumption of the poison. |
|
| ExclusionCriteria |
| Details |
1. Patients less than 18 years.
2. Co-ingestion of organophosphorus compounds with other agents.
3. Patient with autoimmune diseases.
4. Prior history of Iron deficiency anemia, Vitamin B12 deficiency and folate deficiency anemia.
5. Recent hemorrhage.
6. Chronic liver disease.
7. Prior chemotherapy.
8. Patient on oral contraceptive pills.
9. Patient on estrogen therapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
;RDW and CRP
Can be used as a prognostic marker in the assessment of severity of OP compound poisoning .Thus help in anticipating complications and addressing them appropriately.
|
on the day of admission and 48 hours after admission
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
RDW and CRP
Can be used as a prognostic marker in the assessment of severity of OP compound poisoning .Thus help in anticipating complications and addressing them appropriately.
|
on the day of admission and 48 hours after admission
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/12/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
organophosphate (OP) compounds are frequently used as pesticides in countries like ours ,where a great deal of agricultural activities are involved.The ease of availability of the OP compounds has resulted in a gradual increase in unintentional and suicidal poisoning,mainly in developing countries.The world health organization (WHO) has estimated that more than 300 million acute pesticide poisoning occur worldwide each year and most of these cases are due to OP intoxication.The mortality rate of acute OP poisoning is 10%-20% and WHO has estimated that 2,00000 people die each year from pesticide poisoning.Elevated Red cell distribution Width is found in systemic inflammation and oxidative stress.The exact underlying mechanism is not well understood .Oxidative stress is defined as disturbance of the balance between the production of free radicals and the antioxidant capacity of the body.More severe the poisoning more is the production of free radicals and more oxidative stress.Increased oxidative stress contributes to an increase in lipid per oxidation and decrease in the phospholipids content of the erythrocyte membrane.As a result the erythrocyte membrane is damaged and erythrocytes lose their integrity.The lifespan of mature erythrocytes is shortened.In OP poisoning ,there is acute inflammation and increased oxidative stress that can lead to a change in the structure and size of the circulating erythrocyte .Hence it is expected that RDW levels may be increased in OP poisoning and thus can aid in prognosis.CRP is an acute phase reactant that can be used for monitoring of infection or autoimmune disease.In patients with such diseases,cytokine,mainly interleukin-6,stimulates the liver cells and promotes the productions of CRP.In acute OP Poisoning,toxins may cause lesions in tissues and organs in the body, leading to increased plasma CRP levels.We intend to evaluate utility of these two routinely available and inexpensive tests in prognostication of OP poisoning.
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