| CTRI Number |
CTRI/2026/03/105556 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Roe of complet Blood count parameter to know the death pattern in widespread abdominal infection in intensive care setting. |
|
Scientific Title of Study
|
Using blood indices as mortality predictor in abdominal sepsis in intensive care unit :A prospective observational study |
| 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 Manvee Johra |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences(IMS) ,Banaras Hindu University |
| Address |
Department of Anaesthesiology ,Institute of Medical Sciences (IMS),Banaras Hindu University,Varanasi
Department of Anaesthesiology ,Institute of Medical Sciences (IMS),Banaras Hindu University,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8959310077 |
| Fax |
|
| Email |
manveejohra5800@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghanshyam Yadav |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences(IMS) ,Banaras Hindu University |
| Address |
Department of Anaesthesiology ,Institute of Medical Sciences (IMS),Banaras Hindu University,Varanasi
Department of Anaesthesiology ,Institute of Medical Sciences (IMS),Banaras Hindu University,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8959310077 |
| Fax |
|
| Email |
ghanshyambhu1976@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ghanshyam Yadav |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences(IMS) ,Banaras Hindu University |
| Address |
Department of Anaesthesiology ,Institute of Medical Sciences (IMS),Banaras Hindu University,Varanasi
Department of Anaesthesiology ,Institute of Medical Sciences (IMS),Banaras Hindu University,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8959310077 |
| Fax |
|
| Email |
ghanshyambhu1976@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences (IMS),Banaras Hindu University,Varanasi |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences (IMS),Banaras Hindu University,Varanasi |
| Address |
Department of Anaesthesiology ,Institute of Medical Sciences (IMS),Banaras Hindu University,Varanasi |
| 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 Manvee Johra |
ICU ,Institute of Medical Sciences,Banaras Hindu University |
Department of Anaesthesiology ,Institute of Medical Sciences (IMS),Banaras Hindu University,Varanasi
Varanasi
UTTAR PRADESH |
08959310077
manveejohra5800@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Faculty of Medical Sciences,Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R198||Other specified symptoms and signsinvolving the digestive system and abdomen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ICU patients with abdominal sepsis fulfilling sepsis III criteria for sepsis and septic shock.
Critcally ill patients with abdominal trauma injury severity score more than 25.
|
|
| ExclusionCriteria |
| Details |
Patients not giving consent.
Malignancy of any origin.
Immunodeficiency disorder.
Puerperal sepsis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess CBC indices as mortality predictor in abdominal sepsis in ICU. |
Till death or discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Correlate blood indices with
-Organ dysfunctions
-Blood culture status
2. Overall ICU mortality due to abdominal sepsis |
Till death or discharge |
|
|
Target Sample Size
|
Total Sample Size="186"
Sample Size from India="186"
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)
|
21/03/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
All patients fulfilling the inclusion criteria data will be collected -Complete blood count ,SOFA 2 ,APACHE 2,,Blood culture and sensitivity at confirmation of diagnosis and sepsis period and patients outcome will be followed till death or discharge. |