Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06809868

Conditions

Sepsis

Sepsis and Septic Shock

Sepsis With Multiple Organ Dysfunction (MOD)

Sepsis With Acute Organ Dysfunction

Sepsis, Severe

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

RNA and DNA Sequencing

Study Details

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.

Conditions

Sepsis

Sepsis and Septic Shock

Sepsis With Multiple Organ Dysfunction (MOD)

Sepsis With Acute Organ Dysfunction

Sepsis, Severe

Study ID

NCT06809868

Start date

Feb 14, 2025

Status verified date

Jan, 2026

Completion date

Aug 14, 2028

Anticipated

Primary completion date

Feb 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

116 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with Sepsis

Adult patients (age 18 and older) admitted to the intensive care unit (ICU) meeting Sepsis 3 Criteria.

Healthy Individual Controls

Healthy individuals not admitted to the hospital.

Interventions

RNA and DNA Sequencing

DNA and RNA sequencing will be conducted on both control participants and patients with sepsis who are admitted to the ICU.

Primary outcome measure

  • Immune Aging [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Alexendar R Perez, M.D., Ph.D

415-476-1000Alexendar.Perez@ucsf.edu

Matthieu Legrand, M.D., Ph.D

415-476-1000matthieu.legrand@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Alexendar R Perez, M.D., Ph.D

415-476-1000Alexendar.Perez@ucsf.edu

Matthieu Legrand, M.D., Ph.D

415-476-1000matthieu.legrand@ucsf.edu

Principal Investigator:

Alexendar R Perez, M.D., Ph.D

More Information

Sponsor

University of California, San Francisco

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • Sepsis
  • Transposable Elements
  • Immune Aging
  • Mortality
  • Secondary Infections
  • Critical Care Medicine (ICU)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-01-30.