| CTRI Number |
CTRI/2024/07/070412 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
classifying sepsis severity with the help of simple blood parameter like RDW(red cell distribution width). |
|
Scientific Title of Study
|
Clinical utility of red cell distribution width as a prognostic marker in sepsis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KILLAMSETTY ADITYA SAI |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College,Manipal |
| Address |
Department of General Medicine,Kasturba Medical College,Manipal
Udupi KARNATAKA 576104 India |
| Phone |
7008839955 |
| Fax |
|
| Email |
adityakillamsetty692@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
VASUDEVA ACHARYA |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department Of General Medicine, Kasturba Medical College, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8197597008 |
| Fax |
|
| Email |
acharya.vasudev@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
VASUDEVA ACHARYA |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department Of General Medicine, Kasturba Medical College, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8197597008 |
| Fax |
|
| Email |
acharya.vasudev@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine,Kasturba Hospital,Tiger Circle,Manipal,Udupi,Karnataka,Pin-576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of General Medicine,Kasturba Medical College and Hospital,Tiger circle,Manipal,Udupi,Karnataka,Pin-576104 |
| 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 |
| Killamsetty Aditya Sai |
Kasturba Medical College,Manipal |
Department of General Medicine, Kasturba Medical College,Manipal Udupi KARNATAKA |
7008839955
adityakillamsetty692@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITEE-2 (STUDENT RESEARCH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Observational Study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
The patients whose sepsis criteria were met during admission were included in the study.
Patients (18 years and older) diagnosed with sepsis according to established criteria – SEPSIS 3
guidelines-SOFA score
Sepsis is considered if the patient had a confirmed or suspected infection with organ dysfunction
represented by an increase of SOFA score of 2 or more points |
|
| ExclusionCriteria |
| Details |
Patients with pre-existing hematological disorders affecting RDW
Iron Deficiency Anemia(hb<12 in females,hb<13 in males)
B12 & Folate deficiency
Sickle cell anemia.
Pregnancy.
CKD-ESRD/Stage>3
Recent blood transfusions in last 1 month
Recent surgeries,trauma
Chronic alcoholics. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Exploring the clinical utility of red cell distribution width (RDW) in predicting outcome in sepsis patients. |
2 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To determine the risk factors in patients admitted with sepsis.
-To compare RDW with other inflammatory markers of sepsis. |
2 Years 3 Months. |
|
|
Target Sample Size
|
Total Sample Size="160" Sample Size from India="160"
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)
|
22/07/2024 |
| 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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study will be done after obtaining approval from IEC and CTRI clearance. The written consent will be taken from all the patients in the language that they understand. If the patient is not able to give consent then consent shall be taken from the next kin. Our study is a prospective, longitudinal study that includes patients who are diagnosed with sepsis. Patients will be recruited from wards and ICUs admitted under the Department of General Medicine during the study period. RDW shall be noted at the time of presentation to the hospital. SOFA score of the patients will be calculated initially to diagnose sepsis. Serial RDW levels might be collected from the labs if available. The patient will be observed throughout his stay in the hospital until he recovers or expires. The outcome will be noted. Patients will be followed up for 1 month. Patients who leave against medical advice will not be included in the study. Other important data like the hospital number of the patient, history of present illness, comorbidities, habits like alcohol and smoking, laboratory parameters like LFT, RFT, electrolytes, blood culture sensitivity, urine, and pus culture sensitivity will be noted if available. Examination findings including vitals and systemic examination findings shall be noted. XRAY, ECG, duration of hospital stay, ionotropic requirement, dialysis requirement, and duration of ICU stay shall also be noted. Patient safety and confidentiality will not be compromised throughout the study. |