| CTRI Number |
CTRI/2026/04/109073 [Registered on: 22/04/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation Of The De Ritis Ratio (AST/ALT) In Patients With Sepsis At Kle Dr.Prabhakar Kore Hospital &Mrc |
|
Scientific Title of Study
|
To Study De Ritis Ratio In Patients With Sepsis Admitted In Kle Dr.Prabhakar Kore Hospital& Mrc |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Sree Durga Muddamsetty |
| Designation |
Post graduate |
| Affiliation |
Jawaharlal Nehru Medical College,Belagavi 590010 |
| Address |
PG Resident OF General Medicine Jawaharlal Nehru Medical College ,KLE Academy Of Higher Education And Research Centre Belagavi
590010
Karnataka
India
Belgaum
KARNATAKA
590010
India |
| Phone |
7989058751 |
| Fax |
|
| Email |
divyamuddamsetty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dnyanesh N Morkar |
| Designation |
Professor General Medicine |
| Affiliation |
Jawaharlal Nehru Medical College,Belagavi 590010 |
| Address |
Department Of General Medicine
Jawaharlal Nehru Medical College ,KLE Academy Of Higher Education And Research Centre Belagavi
590010
Karnataka
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9448231298 |
| Fax |
|
| Email |
dnyaneshmorkar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Sree Durga Muddamsetty |
| Designation |
Post graduate |
| Affiliation |
Jawaharlal Nehru Medical College,Belagavi 590010 |
| Address |
PG Resident OF General Medicine Jawaharlal Nehru Medical College ,KLE Academy Of Higher Education And Research Centre Belagavi
590010
Karnataka
India
Belgaum
KARNATAKA
590010
India |
| Phone |
7989058751 |
| Fax |
|
| Email |
divyamuddamsetty@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Jawaharlal Nehru Medical College Nehru Nagar, Belagavi 590010
Karnataka
India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DIVYA SREE DURGA MUDDAMSETTY |
Jawaharlal Nehru Medical College Nehru Nagar, Belagavi 590010
Karnataka
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya Sree Durga Muddamsetty |
Dr KLEs Prabhakar Kore Hospital |
Department of General MedicineJawaharlal Nehru Medical College Nehru Nagar Belagavi 590010
Karnataka
India
Belgaum
KARNATAKA |
7989058751
divyamuddamsetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Ethical Institutional Committee Jawaharlal Nehru Medical College, Nehru Nagar , Belagavi -590010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult Patients above 18Years Diagnosed with sepsis according to Sepsis 3 criteria on admission |
|
| ExclusionCriteria |
| Details |
1.Patients With Known Case Of Chronic Liver Disease
2.Patients With Known Of Kidney Disease
3.Patients With Known ase of Hematological Malignancy
4.Patients with Known case Of Inherited Metabolic Disorde
5.Patients With Known Case Of Heart Failure
6.Patients with Known Case of Autoimmune Disease
7.Patients Undergone Massive Blood Transfusion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hospital stay in patients with sepsis assessed in relation to De Ritis ratio at admission |
At time of admission and discharge De Ritis Ratio is assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SOFA score |
Day 1 |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
02/05/2026 |
| 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 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, defined as life-threatening organ dysfunction resulting from a dysregulated host response to infection, continues to represent a significant clinical challenge in critical care medicine. Despite advances in antimicrobial therapy and supportive care, severe sepsis is associated with high morbidity and mortality rates, underscoring the urgent need for reliable biomarkers that can facilitate early risk stratification and guide therapeutic decision-making. The De Ritis ratio, calculated as the serum aspartate aminotransferase (AST) to alanine aminotransferase (ALT) ratio, has long been utilized in hepatology to distinguish between various patterns of liver injury. However, emerging evidence suggests that this ratio may also serve as a prognostic indicator in a range of systemic conditions, including malignancies, cardiovascular disorders, and infectious diseases. Its utility in the context of sepsis, particularly as a marker of disease severity and outcome prediction, is a promising area of investigation |