Role of Transposable Elements in Septic Immune Aging

Recruiting

• Conditions: Sepsis; Sepsis and Septic Shock; Sepsis With Multiple Organ Dysfunction (MOD); Sepsis With Acute Organ Dysfunction; Sepsis, Severe; Sepsis at Intensive Care Unit; Sepsis, Severe Sepsis and Septic Shock; Sepsis, Septic Shock

• Registration Number: NCT06809868
• Lead Sponsor: University of California, San Francisco

Brief Summary

The goal of this observational study is to learn about how transposable element levels affect the patient outcomes in sepsis. The main questions it aims to answer is:

1. Do transposable elements prematurely age the immune systems of patients with sepsis?

2. Do transposable elements correlate with increased mortality in patients with sepsis in the ICU?

3. Do transposable elements correlate with increased amount of secondary infections in patients with sepsis in the ICU?

Participants will have blood drawn from them but will not be subjected to additional interventions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-01-30
• Study First Posted: 2025-02-05
• Study Start: 2025-02-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2026-02-14
• Study Completion: 2026-08-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Age 18 or older
• Admitted to ICU with sepsis (Sepsis 3 Criteria)
• SOFA score of at least 2 at time of enrollment

Exclusion Criteria

• Patients on organ transplantation immunosuppression
• Patients with preexisting leukopenia
• Cancer patients receiving CAR-T therapy
• Patients who are under 18 years of age or otherwise deemed pediatric
• Patients with an ongoing bleeding diathesis (ie: DIC, hemorrhagic shock)
• Patients with a chronic hemoglobin below 7.0
• Patients who, prior to their ICU admission, are blood transfusion dependent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immune Aging	6 weeks

Secondary Outcome Measures

Name	Time	Method
Mortality (30-day)	30 days
Secondary Infection	30 days

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States