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Recruiting NCT06809868

Role of Transposable Elements in Septic Immune Aging

— Observational Sepsis Sepsis and Septic Shock Sepsis With Multiple Organ Dysfunction (MOD) Sepsis With Acute Organ Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RNA and DNA Sequencing.
Who it may be relevant to
Registry conditions: Sepsis, Sepsis and Septic Shock, Sepsis With Multiple Organ Dysfunction (MOD), Sepsis With Acute Organ Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Genetic 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 measures

  • Immune Aging [Time frame: 6 weeks]
Secondary outcome measures (2)
  • Mortality (30-day) [Time frame: 30 days]
  • Secondary Infection [Time frame: 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT06809868 · 23-39420

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗