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Immunoinflammatory Regulation of Esketamine in Septic Patients

StatusTerminated
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial terminated Sponsor's reason: Due to changes in the study plan, no significant clinical benefit was observed, but no adverse events occurred either. Final enrollment: 10 participants (planned 100) · Primary completion date changed from estimate of Oct 30, 2026 to Jan 1, 2026 · Study sites: 2 to 1 · 1 more Show 4 more changesShow less
    • Final enrollment: 10 participants (planned 100)
    • Primary completion date changed from estimate of Oct 30, 2026 to Jan 1, 2026
    • Study sites: 2 to 1
    • Eligibility criteria expanded, about 17 words
  2. Primary and study completion dates: Mar 30, 2025 to Oct 30, 2026v8
  3. Primary completion date: Sep 30, 2024 to Mar 30, 2025 Completion date: Dec 31, 2024 to Mar 30, 2025v7 Show 1 more changeShow less
    • Completion date: Dec 31, 2024 to Mar 30, 2025
  4. Secondary endpoints: 16 to 22v6 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Sep 30, 2022 to Sep 30, 2024 Completion date: Dec 31, 2022 to Dec 31, 2024 · Site contacts updated at 1 of 2 sitesv4 Show 2 more changesShow less
    • Completion date: Dec 31, 2022 to Dec 31, 2024
    • Site contacts updated at 1 of 2 sites
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2 · Start date changed from estimate of Jul 20, 2021 to Jul 28, 2021v3 Show 2 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Jul 20, 2021 to Jul 28, 2021
  3. Start date: Jun 1, 2021 to Jul 20, 2021 Primary endpoints: 5 to 7 · Secondary endpoints: 17 to 16v2 Show 2 more changesShow less
    • Primary endpoints: 5 to 7
    • Secondary endpoints: 17 to 16

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Studies have shown that excessive systemic inflammatory response and concomitant immunosuppression are the main cause of early death in patients with sepsis. Therefore, it is very important to reduce excessive inflammation and improve immunosuppression in the acute phase of sepsis. Clinical studies have shown that esketamine combined with propofol for sedation has been proven to be safe and effective for septic patients in the ICU due to its cardiovascular stability. Previous studies have demonstrated that esketamine has anti-inflammatory effects against depression and surgical stress. Our preliminary experimental studies have found that esketamine had strong anti-inflammatory effects in the acute phase of sepsis. However, it is not clear whether esketamine could reduce excessive inflammation and improve immunosuppression in septic patients primarily sedated with a continuous infusion of propofol. This intervention study is to investigate whether three consecutive days of intravenous esketamine infusions via infusion pump (0.07 mg/kg/h) could reduce excessive inflammation and improve immunosuppression in septic patients requiring mechanical ventilation in the ICU under sedation primarily with propofol.
Trial Details
NCT Number NCT04843982
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Esketamine, Sepsis, Inflammatory Response, Immunosuppression
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov