nderstanding the effects of bacteria in the blood of critically ill patients

Not Applicable

• Conditions: Health Condition 1: D899- Disorder involving the immune mechanism, unspecified

• Registration Number: CTRI/2022/01/039393
• Lead Sponsor: Manipal Academy of Higher Education Manipal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Group 1:

1. Adult patients (>=18 years) admitted to ICU with preexisting septicaemia and sepsis

2. SOFA score >=2

3. Needs vasopressor therapy to elevate mean arterial pressure >=65 mmHg and lactate >2mmol/L (18mg/dL) despite adequate fluid resuscitation

4. Culture positivity for E. coli within 48 hours from the time of first blood sample drawn for culture testing

Group 2:

1. Adult patients (>=18 years) who were admitted to wards/ICU with preexisting bacteremia

2. SOFA score <2

3. Culture positivity for E. coli within 48 hours from time of first blood sample drawn for culture testing.

Group 3:

1. Healthy adult volunteers (>=18 years and not admitted to the hospital) or those with well-controlled underlying conditions (hypertension, diabetes etc.)

2. Able and willing to complete the informed consent process

3. Volunteer must agree to have blood stored and used for this study (within the scope of the approved duration and purposes of this study)

Exclusion Criteria

Group 1 and 2:

1. Pregnant or lactating women

2. Documented immunocompromised clinical status

3. Chronic kidney disease and/or on dialysis

4. Blood transfusion >4 units in the past week

5. Undergone surgeries, grafts, transfusions or extra-corporeal circulation in the last 6 months

6. Prolonged antibiotic usage in the last 3 months

7. History of sepsis/septic shock in the last 6 months

8. Anticipated hospitalization of <=2 days

9. Second admission or transfer from other hospital ICUs or previous enrolment in the study

10. Restricted liberty or under legal protection

11. Inability to get consent

Group 3:

1. Pregnant or breast-feeding

2. Infected with any infectious diseases

3. Hemophilia, severe coagulation disorders or impaired venous access

4. Prolonged antibiotic usage in the last 3 months

5. History of sepsis/septic shock in the last 6 months

Study & Design

• Study Type: Observational
• Study Design: Not specified