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CTRI Number  CTRI/2025/07/091709 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 24/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding outcomes of sepsis through blood proteins and hematocrit level difference 
Scientific Title of Study   To study the relationship between hematocrit and serum albumin levels difference and mortality in sepsis patients 
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 Akshay Manik Padwal 
Designation  Junior Resident  
Affiliation  Datta Meghe Institute Of Higher Education and Research 
Address  Dept. Of General Medicine, JNMC, DMIHER, Sawangi (M), Wardha, Maharashtra – 442001
Samarthnagri sector no.3 ,Indryaninagar bhosari pune 411039
Wardha
MAHARASHTRA
442001
India 
Phone  7769097474  
Fax    
Email  drakshaypadwal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Sarode 
Designation  Professor  
Affiliation  Datta Meghe Institute Of Higher Education and Research 
Address  Dept. Of General Medicine, JNMC, DMIHER, Sawangi (M), Wardha, Maharashtra – 442004
Krishna hospital,Bachelor road ,Wardha,Maharashtra 442004
Wardha
MAHARASHTRA
442001
India 
Phone  7020375582  
Fax    
Email  drrajeshmed@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rajesh Sarode 
Designation  Professor  
Affiliation  Datta Meghe Institute Of Higher Education and Research 
Address  Dept. Of General Medicine, JNMC, DMIHER, Sawangi (M), Wardha, Maharashtra – 442004
Krishna hospital,Bachelor road ,Wardha,Maharashtra 442004
Wardha
MAHARASHTRA
442001
India 
Phone  7020375582  
Fax    
Email  drrajeshmed@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Reasearch ,JNMC, Sawangi ( Meghe ) , Wardha ,Maharashtra ,India 442004 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Datta Meghe Institute of Higher Education and Reasearch ,JNMC, Sawangi ( Meghe ) , Wardha ,Maharashtra ,India  
Type of Sponsor  Research institution and hospital 
 
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 
Dr Akshay Manik Padwal  Datta Meghe Institute of Higher education and Research   Dept. Of General Medicine, JNMC, DMIHER, Sawangi (M), Wardha, Maharashtra – 442001 Dept. Of General Medicine, JNMC, DMIHER, Sawangi (M), Wardha, Maharashtra – 442004
Wardha
MAHARASHTRA 
07769097474

drakshaypadwal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta meghe institute of higher education and research institutional ethics committee  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  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients who have symtomps and are diagnosed with Sepsis based on clinical WHO specified at AVBRH, Sawangi. 
 
ExclusionCriteria 
Details  Patients with prior history of antibiotics ruled out by history and documentation of blood/urine investigations if available
Patients with no document/report available of sepsis
Pregnant patients  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To correlate difference between hematocrit and serum albumin values in the severity of sepsis patients at the time of admission   At the time of Admission 
 
Secondary Outcome  
Outcome  TimePoints 
To compare levels of serum albumin, and haematocrit as a predictor outcome in patients with sepsis  At the time of Discharge or Death 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   15/08/2025 
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  
Sepsis is a life-threatening condition resulting from a dysregulated immune response to infection, frequently encountered in ICU patients. Despite advances in medical care, it remains a significant global health issue, affecting over 30 million individuals annually with a mortality rate of 17%. The condition is especially prevalent and severe in the elderly, due to age-related immune dysfunction and prolonged inflammatory responses, leading to increased mortality.

Serum albumin (ALB), the most abundant plasma protein, plays a vital role in maintaining osmotic pressure and transporting substances, and is widely used as a prognostic marker in critically ill patients. Hypoalbuminemia is common in sepsis and is associated with poor outcomes. Hematocrit (HCT), which reflects the proportion of red blood cells, may increase due to hemoconcentration or chronic hypoxia and is also recognized as a potential predictor of mortality in sepsis.

Both HCT and ALB levels are normally stable in healthy individuals but may fluctuate significantly in sepsis due to increased capillary permeability, inflammation, metabolic changes, and blood loss. The difference between HCT (%) and ALB (g/L), referred to as the HCT-ALB difference, has emerged as a potentially useful marker for assessing disease severity and prognosis in infectious conditions
 
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