| 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
|
|
|
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
|
|
|
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 |