| CTRI Number |
CTRI/2025/03/082877 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of sepsis markers in decortication cases |
|
Scientific Title of Study
|
COMPARISON OF IL-6, PROCALCITONIN AND CRP IN THE POST-OPERATIVE COURSES AFTER LUNG DECORTICATION. |
| 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 |
Dr Sankara Narayanan R |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Department of Anaesthesiology,
King Georges Medical University,
Shah Mina Road,
Chowk, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7667369369 |
| Fax |
|
| Email |
sankarnarayanan1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vipin Kumar Singh |
| Designation |
Additional Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Anaesthesiology,
King Georges Medical University,
Shah Mina Road,
Chowk, Lucknow.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
6387908355 |
| Fax |
|
| Email |
vipintheazad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vipin Kumar Singh |
| Designation |
Additional Professor |
| Affiliation |
King Georges Medical University |
| Address |
Department of Anaesthesiology,
King Georges Medical University,
Shah Mina Road,
Chowk, Lucknow.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
6387908355 |
| Fax |
|
| Email |
vipintheazad@gmail.com |
|
|
Source of Monetary or Material Support
|
| No monetary funding and Infrastructural support by Department of Anaesthesiology, King Georges Medical University, Lucknow-226003, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Sankara Narayanan R |
| Address |
Department of Anaesthesiology,
King Georges Medical University,
Lucknow-226003,
Uttar Pradesh. |
| Type of Sponsor |
Other [SELF] |
|
|
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 Sankara Narayanan R |
King Georges Medical University |
Department of General Surgery, Unit 8, Pulmonary surgery unit, King Georges Medical University
Shah Mina Rd, Chowk.
Lucknow
UTTAR PRADESH |
7667369369
sankarnarayanan1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, King Georges Medical University, U.P., |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J86||Pyothorax, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BLOOD investigations. |
I will compare the preoperative and post operative Day 1 blood investigation such as Procalcitonin, Interleukin-6 and C-reactive Protein. |
| Intervention |
Decortication Surgery |
Patient with Pleural empyema undergoing Decortication surgery is the intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinically proven pleural empyema cases. |
|
| ExclusionCriteria |
| Details |
1) Emergency surgery
2) Pre operative anti-inflammatory drugs intake
3) Pre operative infections treated with corticosteroids and immunosuppressive drugs.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| to know the sensitivity of procalcitonin as a marker of sepsis |
5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| incidence of sepsis after decortication surgeries |
5 days |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
03/03/2026 |
| 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="1"
Months="6"
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
|
This study is the prospective cohort, investigating the association between early (first postoperative day) changes in interleukin-6 (IL-6), procalcitonin (PCT) and C-Reactive Protein (CRP) serum concentration and occurrence of subsequent septic complication after lung decortication. The benefits of the study is to access the accuracy of the procalcitonin as a marker of post-operative infection after decortication surgery and to compare it with IL-6 and C-Reactive protein. |