Friend or Foe? How Autoimmune Diseases Affect Sepsis Recovery
- Conditions
- Health Condition 1: B999- Unspecified infectious disease
- Registration Number
- CTRI/2024/07/070398
- Lead Sponsor
- Kasturba Hospital Manipal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sepsis Severity: Assess the severity of sepsis using the Sequential Organ Failure Assessment (SOFA) scoreTimepoint: Baseline
- Secondary Outcome Measures
Name Time Method ength of Hospital Stay: Evaluate the duration of hospitalisation for sepsis patients with autoimmune diseases in comparision to those without autoimmune diseases.Timepoint: Baseline;Mortality: Determine the mortality rate among patients with autoimmune diseases & sepsis in comparision to those without autoimmune diseases.Timepoint: 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 diseasesTimepoint: Baseline