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Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 7, 2025 (before its estimated July 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Mar 30, 2023 to Jul 30, 2025
    • Study completion date: Aug 30, 2023 to Dec 30, 2025
    v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 10, 2022 to Mar 8, 2022
    v2
  3. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In septic shock there is growing evidence of a state of hemodynamic "disconnection" with seemingly adequate macrocirculatory values despite actual microcirculation failing to meet cellular demand. Norepinephrine (NE) is recommended as first choice vasoactive agent for the treatment of septic shock. However, the dynamic effects of NE on macro- and microcirculation and perfusion parameters has not been described in detail in the context of septic shock, precluding rational individualized titration of NE and fluids, as recommended recently. In the present prospective observational multicenter study in adult septic shock patients, we intend to explore the effects of NE on preload dependency and tissue perfusion by evaluating the correlation and potential discrepancies between macro- and microcirculation both during titration of NE and after fluid resuscitation. The conclusions drawn from our study will contribute to the physiological knowledge necessary for establishing individualized evidence-based bedside management of hemodynamics in the setting of septic shock.
Trial Details
NCT Number NCT05225402
Lead Sponsor Copenhagen University Hospital, Hvidovre
Collaborators: University Hospital Bispebjerg and Frederiksberg
Conditions
(from sponsor)
Septic Shock, Hemodynamic Instability, Vasoconstriction
Related terms Shock, Septic
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov