Correlation of Memory CD8+ T Cells With Sepsis Severity and Mortality: a Single-center, Unblinded, Prospective, Non-interventional, Observational Study

StatusRecruiting
PhaseNot specified
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 60 days later Aug 31, 2026 → Oct 30, 2026
See other at-risk trials from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 31, 2026 to Oct 30, 2026
    • Study completion pushed from Sep 30, 2026 to Nov 30, 2026
  2. Enrollment increased: 30 → 80 participantsv11
  3. Enrollment target: 16 to 30v10 Show 5 more changesShow less
    • Primary completion date: Nov 3, 2024 to Aug 31, 2026
    • Trial status: Completed to Recruiting
    • Study completion date: Nov 3, 2024 to Sep 30, 2026
    • Secondary endpoints: 17 to 18
    • Site details revised
  4. Trial status: Recruiting to Completedv9 Show 5 more changesShow less
    • Enrollment target: estimated 80 to confirmed 16
    • Primary and study completion dates changed from estimate of Oct 30, 2025 to Nov 3, 2024
    • Start date: Oct 10, 2024 to Sep 6, 2023
    • Site details revised
    • Study arms: 3 to 2
  5. Trial status: Not Yet Recruiting to Recruitingv8 Show 4 more changesShow less
    • Primary completion date: May 30, 2025 to Oct 30, 2025
    • Study completion date: Jun 30, 2025 to Oct 30, 2025
    • Start date changed from estimate of May 20, 2025 to Oct 10, 2024
    • Site details revised
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Dec 24, 2024 to May 20, 2025
    • Primary completion date: Apr 30, 2025 to May 30, 2025
    • Study completion date: May 31, 2025 to Jun 30, 2025
    v7
  2. Start date: Feb 24, 2024 to Dec 24, 2024
    • Trial status: Recruiting to Not Yet Recruiting
    • Site details revised
    v6
  3. Start date: Nov 24, 2023 to Feb 24, 2024v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 20, 2023 to Nov 24, 2023
    • Primary endpoints: 9 to 10
    • Site details revised
    v4
  5. Start date: Jul 20, 2023 to Sep 20, 2023
    • Trial status: Recruiting to Not Yet Recruiting
    • Site details revised
    v3
  6. Start date: May 20, 2023 to Jul 20, 2023v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sepsis is defined as a life-threatening organ dysfunction that is caused by a dysregulated host response to infection. Severe sepsis is the most common cause of death among critically ill patients in non-coronary intensive care units (ICU). Sustained excessive inflammation and immune dysfunction have been confirmed to play a key role in organ damage and early death of sepsis patients. Therefore, it is important to reduce excessive inflammatory response mediated by immune cells and pro-inflammatory cytokines in the acute phase of sepsis. Single-cell RNA sequencing performed on both septic patients and mice suggest that changes in Tcm (CD3+ CD8+ CD44+ CD127+ CD62L+) and Tem (CD3+ CD8+ CD44+ CD127+ CD62L -) in the acute phase of sepsis may play an important role in sepsis. In addition, animal researches showed that Tcm and Tem decreased decreased continuously at 24, 48 and 72h after cecal ligation and perforation (CLP) in mice, and the adoptive transfer of Tcm , sorting from spleen of mice 24h after CLP , but not Tem improved 7-day survival rate of sepsis mice. This observational study is aimed to investigate the quantity and proliferation of Tcm and Tem in the acute phase of sepsis and their correlation with severity level and mortality of septic patients in ICU.
Trial Details
NCT Number NCT05875740
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions
(from sponsor)		 Sepsis, Inflammatory Response
Related terms Sepsis
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov