| CTRI Number |
CTRI/2024/08/072884 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Monocyte characteristics for early detection of infection in patients. |
|
Scientific Title of Study
|
Monocyte Distribution Width (MDW) as a useful indicator for early screening of sepsis and efficacy in screening patients with positive blood culture: 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 Priyanka mohapatra |
| Designation |
Senior resident |
| Affiliation |
Ruby Hall Clinic, Pune |
| Address |
Intensive Care Unit, 1st floor, Ruby Hall Clinic, Sassoon road, Pune, Maharashtra
Pune MAHARASHTRA 411001 India |
| Phone |
9777600155 |
| Fax |
|
| Email |
PRIYANKAMOHAP@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanmay Chaudhary |
| Designation |
Consultant |
| Affiliation |
Ruby Hall Clinic Pune |
| Address |
Intensive Care Unit, 1st floor, Ruby Hall Clinic, Sassoon road, Pune, Maharashtra
Pune MAHARASHTRA 411001 India |
| Phone |
9822058461 |
| Fax |
|
| Email |
dr.sanmay@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Priyanka mohapatra |
| Designation |
Senior resident |
| Affiliation |
Ruby Hall Clinic Pune |
| Address |
Intensive Care Unit, 1st floor, Ruby Hall Clinic, Sassoon road, Pune, Maharashtra
Pune MAHARASHTRA 411001 India |
| Phone |
9777600155 |
| Fax |
|
| Email |
PRIYANKAMOHAP@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Ruby Hall Clinic, Sassoon road, Pune, Maharashtra, Pincode-411001 |
|
|
Primary Sponsor
|
| Name |
RUBY HALL CLINIC |
| Address |
Ruby Hall Clinic, Sassoon road, Pune, Maharashtra, Pincode-411001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 PRIYANKA MOHAPATRA |
RUBY HALL CLINIC |
INTENSIVE CARE UNIT Pune MAHARASHTRA |
9777600155
PRIYANKAMOHAP@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE BIOMEDICAL AND HEALTH RESEARH POONA MEDICAL HEALTH RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R798||Other specified abnormal findingsof blood chemistry, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Admitted in ICU in Ruby Hall clinic with suspicion of sepsis as defined by sepsis 3 criteria
2. Those whose complete blood count, blood culture and other lab tests will be sent within 12hours of admission |
|
| ExclusionCriteria |
| Details |
1. Patients with an inadequately low monocyte count (less than 100/μl)
2. Patients with a history of onco-haematological disease, immunocompromised, that could affect monocyte size and activation in response to infection.
3. Pregnant women
4. Patients admitted more than once to prevent duplication of data. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients will be grouped into blood culture positive and negative and Monocyte Distribution width, C-reactive protein (CRP), and Procalcitonin (PCT) value will be correlated with the blood culture and other cultures in all the groups. |
within 2years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient with above parameters like MDW, PCT, CRP and Neutrophil: lymphocyte ratio value will be correlated for each group and the significance of MDW in predicting sepsis. |
within 2years |
| -MDW efficacy in predicting sepsis in comparison to PCT and its variability in different group of patients. |
within 2 years |
| A follow-up of MDW, PCT, and CRP will be performed later in the course of sepsis among survivors and non-survivors to assess the prognostic value. |
within 2 years |
| -Using MDW as prognostication marker to see the length of ICU stay. |
within 2years |
|
|
Target Sample Size
|
Total Sample Size="105" Sample Size from India="105"
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)
|
01/09/2024 |
| 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) |
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
|
Monocytes can contribute to the process of inflammation or infection by secreting cytokines, however, there is increasing evidence that monocytes undergo morphological changes, including volume increase, during inflammatory or infectious processes and sepsis. Polilli et al compared patients with no sepsis, sepsis, and septic shock and found that MDW values were significantly higher in patients with sepsis or septic shock than in the no sepsis group. As MDW increases in response to bacterial infection in the blood, MDW is related to the blood culture results. Although the blood culture test is the gold standard in diagnosing bacterial infections in the blood, low sensitivity, and false positivity are still valid concerns
Patients to be admitted will be categorized into 3 groups: sepsis, probable sepsis, and control group according to sequential organ failure assessment (SOFA) criteria and Sepsis-3 criteria definitions. Institutions Sepsis Code activation in ER, will also be used as an enrolling tool in this study.
A control group will be taken comprising of patients with no evidence of infection like patients presenting to ICU with Cerebrovascular accident (CVA) without aspiration, class I (clean) post-operative care patients, and head trauma patients. All routine blood investigations will be sent including Complete Blood Count (CBC), MDW, and Procalcitonin (PCT), along with all other tests that could define infection, like imaging. Blood culture sensitivity (One set of aerobic and anaerobic/ Two sets of aerobic and anaerobic from two different sites if an invasive medical device is present) will be sent in all patients using all standard aseptic precautions. Other cultures will be sent as per the cause of sepsis suspicion. |