| CTRI Number |
CTRI/2024/07/070398 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Friend or Foe? How Autoimmune Diseases Affect Sepsis Recovery |
|
Scientific Title of Study
|
Role of Autoimmune Diseases in Sepsis Outcomes |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adarsh |
| Designation |
Junior resident |
| Affiliation |
Kasturba medical college Manipal |
| Address |
Department of General Medicine
3rd floor
New opd building
Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8971881305 |
| Fax |
|
| Email |
adarshsangathi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Bhat |
| Designation |
Professor and Head of the Unit |
| Affiliation |
Kasturba medical college Manipal |
| Address |
Department of General Medicine
3rd floor
New opd building
Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945272251 |
| Fax |
|
| Email |
ram.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Adarsh |
| Designation |
Junior resident |
| Affiliation |
Kasturba medical college Manipal |
| Address |
Department of General Medicine
3rd floor
New opd building
Kasturba Hospital Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8971881305 |
| Fax |
|
| Email |
adarshsangathi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital
Madhavnagar Manipal
Karnataka India 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital Manipal |
| Address |
Madhavnagar Manipal
Karnataka India 576104 |
| 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 Adarsh |
Kasturba Hospital |
Department of General Medicine 3rd floor
New opd building
Madhavnagar Manipal Karnataka India 576104
Udupi
KARNATAKA |
8971881305
adarshsangathi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B999||Unspecified infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Confirmed diagnoses of autoimmune diseases based on established diagnostic criteria (e.g., ACR/EULAR classification criteria).
2. Clinical diagnosis of sepsis according to the Sepsis-3 criteria (SOFA score increase ≥ 2 points due to infection) during hospitalisation.
|
|
| ExclusionCriteria |
| Details |
1. Age below 18 years
2. Lack of documented autoimmune disease diagnoses
3. Immunocompromised conditions not associated with autoimmune diseases (e.g.,
HIV/AIDS, solid organ transplantation)
4. Pregnancy, due to potential confounding effects on sepsis outcomes.
5. Inability to comprehend the study objectives or provide informed consent due to language or cognitive limitations
6. Limited availability for follow-up assessments or intended treatment, including discharge against medical advice |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sepsis Severity: Assess the severity of sepsis using the Sequential Organ Failure Assessment (SOFA) score |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality: Determine the mortality rate among patients with autoimmune diseases & sepsis in comparision to those without autoimmune diseases. |
Baseline |
| Length of Hospital Stay: Evaluate the duration of hospitalisation for sepsis patients with autoimmune diseases in comparision to those without autoimmune diseases. |
Baseline |
| Treatment Responses: Evaluate the influence of immunosuppressive therapies & biologic agents on the clinical trajectories of sepsis-related outcomes in patients with concurrent autoimmune diseases in comparison to those without autoimmune diseases |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
20/07/2024 |
| 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="0"
Months="6"
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
|
STUDY NAME: ROLE OF AUTOIMMUNE DISEASES IN SEPSIS OUTCOMES
AIM OF THE STUDY : TO ELUCIDATE THE RELATIONSHIP BETWEEN AUTOIMMUNE DISEASES AND THEIR ROLE IN SEPSIS OUTCOMES
OBJECTIVES: 1.To investigate predictive factors of sepsis outcomes in individuals with underlying autoimmune diseases. 2.To quantify the severity of sepsis in context of autoimmune diseases using SOFA scoring system. 3. To evaluate the impact of autoimmune disease treatment on sepsis outcomes
STUDY PERIOD: 6 Months
SAMPLE SIZE AND ESTIMATION : The sample size is of 82 participants for whole study. It has been calculated based on multiple regression, as suggested by Green (1991) with the formula N >50 + 8P, where P is the number of independent variables. I.e Predictor variables such as age, sex, SOFA score on admission, and immune modulation medications
DESCRIPTION OF PROCESS : • Participants will be recruited from both the ward and ICU admitted under medicine department. • Written consent will be obtained from each participant or from participant legal representatives (if participant unable to provide consent) before their inclusion in the study. They will be provided with comprehensive information about the study. • Participants will be subjected to detailed history, physical examination, and data will be collected in a structured proforma. • Lab investigations required for SOFA score calculation (PaO2, platelets, Bilirubin, creatinine), CRP, Procalcitonin, NLR ratio, and documented bacteraemia will be collected.
OUTCOME MEASURES:
Primary outcome Measures: 1. Sepsis severity: SOFA score at the time of hospitalisation.
Secondary outcome Measures: 1. Mortality: both in-hospital and at specified follow-up periods. 2. Length of Hospital Stay. 3. Evaluation of Autoimmune disease treatment on sepsis outcomes. |