| CTRI Number |
CTRI/2024/07/069849 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predictive marker in sepsis and septic shock |
|
Scientific Title of Study
|
Hs- Troponin I, as a predictive marker of cardiovascular instability in sepsis and septic shock- A prospective observational study |
| 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 Damerla V N L Prathyusha |
| Designation |
DrNB Resident, Critical Care Medicine |
| Affiliation |
MEDICOVER Hospitals |
| Address |
3rd floor, Dept of Critical care Medicine, Medical ICU, Medicover Hospitals, Opposite CYBER gateway, HITECH City, Hyderabad
Opposite CYBER gateway, HITECH CITY, HYDERABAD
Hyderabad
TELANGANA
500081
India |
| Phone |
9493485491 |
| Fax |
|
| Email |
prathyushadamerla@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganshyam Jagathkar |
| Designation |
Director and HOD of Critical Care Medicine |
| Affiliation |
MEDICOVER HOSPITALS |
| Address |
3rd floor, Dept of Critical care Medicine, Medical ICU, Medicover hospitals, Opposite Cyber gateway, HUDA Techno Enclave, HITECH CITY, HYDERABAD
Opposite CYBER gateway, HITECH CITY, HYDERABAD
Hyderabad
TELANGANA
500081
India |
| Phone |
9949001344 |
| Fax |
|
| Email |
drganshyam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Damerla V N L Prathyusha |
| Designation |
DrNB Resident, Critical Care Medicine |
| Affiliation |
MEDICOVER Hospitals |
| Address |
3rd floor, Dept of Critical care Medicine, Medical ICU, Medicover hospitals, Opposite Cyber gateway, HUDA Techno Enclave, HITECH CITY, HYDERABAD
Opposite CYBER gateway, HITECH CITY, HYDERABAD
Hyderabad
TELANGANA
500081
India |
| Phone |
9493485491 |
| Fax |
|
| Email |
prathyushadamerla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medicover Hospitals, Opposite Cyber gateway, Huda techno Enclave, Hitech city, Hyderabad-500081 |
|
|
Primary Sponsor
|
| Name |
Dr Damerla V N L Prathyusha |
| Address |
Department of Critical Care Medicine, Medical ICU, 3rd floor, Medicover Hospitals, Opposite cyber gateway, Huda Techno enclave, Hitech city, Hyderabad-500081 |
| 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 Damerla V N L Prathyusha |
Medicover Hospitals |
Department of Critical Care Medicine, Medical ICU, 3 rd floor, Medicover Hospitals, Opposite Cyber gateway, Huda Techno Enclave, Hitech City, Hyderabad.
Hyderabad
TELANGANA |
9493485491
prathyushadamerla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Medicover Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. End stage Renal disease with sepsis.
2. Requiring vasopressors and ionotropes |
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years
2.Acute coronary syndrome
3.Myocardial injury, Post cardiac surgery patients
4.Posted for any surgical procedures
5.Immunological disorders
6.Pregnant women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure and determine, Hs-Troponin I level, as a predictive marker of transformation of sepsis into sepsis induced cardiac dysfunction/septic shock in critically ill patients.
|
1.upon admission
2.at 24 hours of admission
3.at the onset of cardiovascular instability |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To follow up the 2D ECHO findings for early recognition and intervention to mitigate the progression into septic shock. |
1.upon admission
2.at 24 hours of admission
3.at the onset of cardiovascular instability |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/07/2024 |
| 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
|
Sepsis often triggers a systemic inflammatory response that can lead to cardiovascular dysfunction, affecting the heart’s ability to pump blood effectively. The heart may experience stress and injury during the progression of sepsis. In situations of cardiac stress or injury, such as during sepsis, troponin I can be released into the bloodstream. •Highly sensitive troponin I (Hs-Tn I) refers to a more advanced and precise assay used to measure troponin I levels in the blood. They provide increased sensitivity, improved specificity, lower detection limit, better monitoring, rapid diagnosis and improved risk stratification. •Increased Hs-troponin I levels in sepsis patients may be associated with a higher likelihood of progression to septic shock. The biomarker provides valuable prognostic information, aiding clinicians in assessing the severity of cardiovascular involvement and predicting the risk of deteriorating into a critical state. Early recognition of cardiac involvement may prompt interventions aimed at preventing or mitigating the progression to septic shock.
|