| CTRI Number |
CTRI/2025/05/086916 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the Use of Albumin and Protein Levels to Predict Recovery in ICU Sepsis Patients. |
|
Scientific Title of Study
|
Prospective Assessment of Albumin/CRP ratio and Albumin/Globulin Ratio as Prognostic Indicators in ICU Sepsis Cases. |
| Trial Acronym |
Not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arvind Kumar Kushwaha |
| Designation |
PhD. Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Ground floor, Department of Biochemistry, JNMC building, Sawangi, Meghe
Wardha
MAHARASHTRA
442005
India |
| Phone |
9981860352 |
| Fax |
|
| Email |
kumararvind2484@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Prakash Anjankar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Ground floor, Department of Biochemistry, JNMC building, Sawangi, Meghe
Wardha
MAHARASHTRA
442005
India |
| Phone |
9970951055 |
| Fax |
|
| Email |
ashish.anjankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Prakash Anjankar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Ground floor, Department of Biochemistry, JNMC building, Sawangi, Meghe
MAHARASHTRA
442005
India |
| Phone |
9970951055 |
| Fax |
|
| Email |
ashish.anjankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi, Meghe, Wardha, India 442001 |
| 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 |
| Dr Arvind Kumar Kushwaha |
Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital |
Department of Biochemistry, Ground floor JNMC Building, Sawangi, Meghe
Wardha
MAHARASHTRA |
9981860352
kumararvind2484@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Datta Meghe Institute of Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
NA |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of sepsis according to symptoms, physical findings and other sepsis biomarkers.
2. ICU admission within 24 hours of diagnosis.
|
|
| ExclusionCriteria |
| Details |
1. Chronic liver disease
2. Chronic nephrotic syndrome
3. Malignancy affecting protein metabolism.
4. Immunocompromised patients.
5. Pregnant patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Worse clinical outcomes, higher mortality, and more severe disease will be linked to a higher CAR and a lower AGR. |
Assessment will be done at 24 hours of admission. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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)
|
01/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 thoughtful clinical problem, and improving patient outcomes requires initial
recognition and risk valuation. The serum albumin/C-reactive
protein (Alb/CRP) ratio and albumin/globulin (A/G) ratio have become predictable
as probable markers of inflammatory retorts and nutritional grade amid the
several biomarkers to assess sepsis. This will be a cross-sectional study conducted at JNMC Wardha and the study aims to assess the albumin/CRP ratio and albumin/globulin
ratio as prognostic indicators in ICU sepsis cases. |