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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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