| CTRI Number |
CTRI/2026/02/103844 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using blood test markers to differentiate types of blood infection in adult patients undergoing heart surgery |
|
Scientific Title of Study
|
Differentiation of culture positive sepsis and culture negative sepsis in adult cardiac surgery patient using biomarkers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| thusharam |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Thushara Madathil |
| Designation |
Additional Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Tower 6, Floor 1, Department of Cardiac Anesthesia, Amrita Hospitals, Amrita Lane, Ponekkara PO, Edapally, Kochi, Kerala, India, 682041
Ernakulam
KERALA
682041
India |
| Phone |
7034028134 |
| Fax |
|
| Email |
ammasthush13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Thushara Madathil |
| Designation |
Additional Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Tower 6, Floor 1, Department of Cardiac Anesthesia, Amrita Hospitals, Amrita Lane, Ponekkara PO, Edapally, Kochi, Kerala, India, 682041
KERALA
682041
India |
| Phone |
7034028134 |
| Fax |
|
| Email |
ammasthush13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Thushara Madathil |
| Designation |
Additional Professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Tower 6, Floor 1, Department of Cardiac Anesthesia, Amrita Hospitals, Amrita Lane, Ponekkara PO, Edapally, Kochi, Kerala, India, 682041
KERALA
682041
India |
| Phone |
7034028134 |
| Fax |
|
| Email |
ammasthush13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences.
Tower 6, Floor 1, Department of Cardiac Anesthesia, Amrita Hospitals, Amrita Lane, Ponekkara PO, Edapally, Kochi, Kerala, India, 682041 |
| NIL |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Science Kochi |
| Address |
Amrita Hospitals, Ponekkara post, Edapally, Kochi, Kerala - 682041 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Randox Laboratories India Pvt Limited |
KIADB Industrial area, 191-195, Bommasandra Jigani Link Road, Bengaluru, Karnataka, 560105 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Thushara Madathil |
Amrita institute of Medical Sciences |
Tower 6, Floor 1, Department of Cardiac Anesthesia, Amrita Hospitals, Amrita Lane, Ponekkara PO, Edapally, Kochi, Kerala, India, 682041
Ernakulam
KERALA |
07034028134
ammasthush13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I208||Other forms of angina pectoris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biomarker assay |
Blood samples to be taken for biomarker assay before surgery and followup to identify sepsis and to study the biomarker trend in culture positive and culture negative sepsis |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients over the age of 18 years undergoing off-pump cardiac surgery. |
|
| ExclusionCriteria |
| Details |
Patients with preoperative colonization or preoperative sepsis, patients on preoperative antibiotics, patients undergoing on-pump cardiac surgery and those who are known cases of autoimmune diseases and blood cell diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the predictability of culture positive and culture negative sepsis in off-pump adult cardiac surgery patient using the Randox Hyperinflammation Biochip [9 biomarkers; Interleukin-1 Beta (IL-1 Beta), Interleukin-2 (IL-2), Interleukin-6 (IL-6),Interferon Gamma (IFN-Gamma), Tumor Necrosis Factor- Alpha (TNF-Alpha), Monocyte Chemoattractant Protein-1 (MCP-1), Interleukin-15 (IL-15), Ferritin and D-Dimer] with the clinical risk scores, the Euroscore II. |
the end point is development of sepsis as per SOFA score rise of more than 2 within the primary postoperative intensive care admission which may last from 2 to 5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the prediction of sepsis by the above-mentioned biomarkers and correlate it to the standard Euro-score II risk prediction of sepsis in cardiac surgery patients. |
During ICU stay and upto 48 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/03/2026 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Sepsis and systemic inflammatory response syndrome are common complications following adult cardiac surgery and are associated with significant morbidity and mortality. Differentiating culture-positive sepsis from culture-negative sepsis in the early postoperative period is clinically challenging, often leading to empirical use of broad-spectrum antibiotics. This prospective Observational Study aims to evaluate the role of of a panel of inflammatory biomarkers in differentiating culture-positive sepsis from culture-negative sepsis in adult patients undergoing off-pump cardiac surgery. Blood samples will be collected at predefined time points before surgery and during the postoperative period for biomarker analysis. Biomarker levels will be compared between patients with culture-positive and culture-negative sepsis and correlated with established clinical risk scores and outcomes. The findings of this study may help in early identification of infection related sepsis, improve risk stratification, and support rational antibiotic use in the postoperative cardiac surgical population. |