Perfusion Efficiency-Guided MAP De-escalation in Elderly Septic Shock

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Record History

  1. Study First Submitted
This is a single-center, prospective, randomized crossover physiological trial conducted in elderly patients (≥65 years) with septic shock in the intensive care unit (ICU). All enrolled patients receive sequential titration of mean arterial pressure (MAP) to three predefined target ranges (60-65 mmHg, 65-70 mmHg, and 70-75 mmHg) in randomized order. The primary objective is to compare tissue perfusion pressure (TPP) between the low and intermediate MAP targets, and to test the non-inferiority hypothesis that the lower MAP target is non-inferior to the intermediate target. Multiple secondary microcirculatory, systemic perfusion, and safety indicators are collected during steady-state hemodynamic periods under each MAP target stage. Researchers will adopt linear mixed-effects models to analyze intra-individual differences across blood pressure targets and explore the MAP threshold for optimal peripheral perfusion. Safety outcomes including adverse hemodynamic events and long-term clinical follow-up data will also be assessed.
Trial Details
NCT Number NCT07887854
Lead Sponsor Peking Union Medical College Hospital
Conditions
(from sponsor)
Sepsis
Related terms Sepsis
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov