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NOT YET RECRUITING
NCT07887854
NA

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Perfusion Efficiency-Guided MAP De-escalation in the Maintenance Phase of Elderly Septic Shock: A Randomized Crossover Non-Inferiority Trial

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-11-01

Completion Date

2027-01-31

Last Updated

2026-10-21

Healthy Volunteers

No

Conditions

Interventions

OTHER

Ascending MAP titration sequence

【Ascending MAP titration sequence】 Sequential adjustment of target mean arterial pressure: 60-65 mmHg → 65-70 mmHg → 70-75 mmHg. Each target level is maintained for fixed observation duration.

OTHER

Descending MAP titration sequence

【Descending MAP titration sequence】 Sequential adjustment of target mean arterial pressure: 70-75 mmHg → 65-70 mmHg → 60-65 mmHg. Each target level is maintained for fixed observation duration.