| CTRI Number |
CTRI/2024/06/069560 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study the prediction of outcome in patients with sepsis using acute phase reactants and SOFA Scoring system. |
|
Scientific Title of Study
|
Prediction of outcome in patients with sepsis using Acute phase reactants and sequential organ functional assessment (SOFA) scoring system. |
| 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 Kajal Magnani |
| Designation |
Junior resident |
| Affiliation |
Dr. D Y Patil School of Medicine, Navi Mumbai |
| Address |
Department of General Medicine, Dr D Y Patil Hospital, 11, Ayyappa Temple Rd, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9909662206 |
| Fax |
|
| Email |
kajalmagnani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Varun Shetty |
| Designation |
Professor |
| Affiliation |
Dr. D Y Patil School of Medicine, Navi Mumbai |
| Address |
Department of General Medicine, Dr D Y Patil Hospital, 11, Ayyappa Temple Rd, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
7021655346 |
| Fax |
|
| Email |
shettyvarun81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kajal Magnani |
| Designation |
Junior resident |
| Affiliation |
Dr. D Y Patil School of Medicine, Navi Mumbai |
| Address |
Department of General Medicine, Dr D Y Patil Hospital, 11, Ayyappa Temple Rd, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9909662206 |
| Fax |
|
| Email |
kajalmagnani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr DY Patil medical college and hospital, Nerul, Navi Mumbai - 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Kajal Magnani |
| Address |
Junior resident, Department of General Medicine, Dr DY Patil Medical College, Navi Mumbai -400706 |
| 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 Kajal Magnani |
Dr DY Patil Hospital, Navi Mumbai |
MICU, 2nd floor, Dr D Y Patil Hospital, Nerul, Navi Mumbai, Thane, Maharashtra 400706
Thane
MAHARASHTRA |
9909662206
kajalmagnani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) for Biomedical and Health Research, Dr DY Patil medical college, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A30-A49||Other bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult males or females fulfilling qSOFA Criteria
Respiratory rate >22/min
GCS<15
SBP<100mmHg |
|
| ExclusionCriteria |
| Details |
1)Patients with Rheumatic Heart Disorder and Collagen Vascular Disease
2)Patients with malignancy
3)Pregnant women
4)Patients who received antibiotics in prior 7 days |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the levels of serum acute phase reactants to reflect the presence and intensity of an inflammatory process in patients with sepsis
|
2 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the mortality in patients with sepsis by correlating the levels of acute phase reactants & SOFA SCORE |
2 days |
|
|
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)
|
06/07/2024 |
| 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="1"
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
|
Introduction Definition Sepsis - Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection; organ dysfunction is defined as an increase of two or more points in the sequential (sepsis-related) organ failure assessment (SOFA) score. Septic shock - Septic shock is defined as sepsis that has circulatory, cellular, and metabolic abnormalities that are associated with a greater risk of mortality than sepsis alone; these abnormalities can be clinically identified as all of the following: Patients who fulfill the criteria for sepsis Patients who, despite adequate fluid resuscitation, require vasopressors to maintain a mean arterial pressure (MAP) ≥65 mmHg Patients who have a lactate >2 mmol/L (>18 mg/dL) Acute phase reactants are elevated in infection, inflammation, trauma and neoplasms. Increasing or persistently high levels suggest a poor prognosis, while declining values are associated with a more favourable prognosis. In the present study, serum ESR, CRP and PCT concentrations of all patients admitted to ICU with sepsis will be measured and their prognostic value will be compared with SOFA SCORE for the assessment of severity and mortality. |