| CTRI Number |
CTRI/2023/01/048903 [Registered on: 11/01/2023] Trial Registered Prospectively |
| Last Modified On: |
10/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Study SOFA (sequential organ failure assessment)score in ICU patients of a tertiary care teaching hospital for Prediction of severity of ICU admitted patients |
|
Scientific Title of Study
|
SOFA (sequential organ failure assessment)score as a prognostic marker in ICU patients of a tertiary care teaching hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pathak Niranjan Pandurang |
| Designation |
Associate Professor |
| Affiliation |
PCMCS PGI YCM hospital |
| Address |
PCMCS PGI YCM hospital Sant tukaram nagar Pimpri-Pune-18
Pune
MAHARASHTRA
411018
India |
| Phone |
9730490292 |
| Fax |
|
| Email |
nrnjnpats@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pathak Niranjan Pandurang |
| Designation |
Associate Professor |
| Affiliation |
PCMCS PGI YCM hospital |
| Address |
PCMCS PGI YCM hospital Sant tukaram nagar Pimpri-Pune-18
Pune
MAHARASHTRA
411018
India |
| Phone |
9730490292 |
| Fax |
|
| Email |
nrnjnpats@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pathak Niranjan Pandurang |
| Designation |
Associate Professor |
| Affiliation |
PCMCS PGI YCM hospital |
| Address |
PCMCS PGI YCM hospital Sant tukaram nagar Pimpri-Pune-18
Pune
MAHARASHTRA
411018
India |
| Phone |
9730490292 |
| Fax |
|
| Email |
nrnjnpats@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PCMCS PGI YCM hospital |
| Address |
PCMCS PGI YCM hospital Sant tukaram nagar Pimpri Pune 18 |
| 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 Niranjan Pathak |
Medicine Department |
Medicine Department Room, 2nd floor, PCMC PGI YCM Hospital,
Pimpri, Pune 18
Pune
MAHARASHTRA |
9730490292
nrnjnpats@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PCMCS PGI YCMH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
cases of septicemia admitted for more than 24 h to the medical ICU. |
|
| ExclusionCriteria |
| Details |
ICU patients who have refused to give consent for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SOFA score is a good prognostic marker in ICU patients of a tertiary care teaching hospital |
After 24 hours |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
15/01/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sepsis is one of the important problems in medicine due to its complexity from pathophysiologic, clinical, and therapeutic viewpoints. Although several deï¬nitions have been proposed for this syndrome, in general, it can be assumed that it represents the clinical manifestation of a systemic response of the body to infection or to an inflammatory-associated acute disease.Mortality rates as a result of sepsis are associated with a pattern characterized by progressive dysfunction or failure of non-pulmonary organ systems, including neurologic, coagulation, and renal functions over the ï¬rst 3 days.[3] Various scoring systems such as Glasgow scale, APACHE II and III and sequential organ failure assessment (SOFA) scoring have been validated and are being used in predicting prognosis of patients admitted in intensive care unit (ICU). In this study, sepsis in the ICU of a tertiary care hospital was evaluated, with speciï¬c reference to clinical features and SOFA score. The SOFA score was calculated to assess the severity of sepsis and multi-organ failure at presentation and after 48 h. These SOFA and mean SOFA scores were correlated with outcomes. Furthermore, multi-organ dysfunction was assessed with respect to organ systems involved and their correlation with mortality. Sequential assessment of organ dysfunction in patients in ICU at presentation and at 48 h, is one of the important parameters for predicting mortality. |