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NCT07887854
Perfusion Efficiency-Guided MAP De-escalation in Elderly Septic Shock
Conditions: Sepsis
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: Peking Union Medical College Hospital
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.
Eligibility Criteria
Inclusion Criteria:
1. Elderly patients (≥65 years) admitted to ICU with septic shock requiring invasive arterial blood pressure monitoring and vasopressor support.
2. Clinically indicated target mean arterial pressure (MAP) range covering 60-75 mmHg.
3. Expected duration of stable hemodynamic status ≥ 150 minutes to complete the crossover titration protocol.
4. Attending intensivist agrees to participate; written informed consent obtained from patient or legally authorized representative.
Exclusion Criteria:
1. Age \< 65 years.
2. Severe aortic stenosis, aortic dissection, or uncontrolled intracranial hypertension requiring fixed high MAP target.
3. Known irreversible terminal condition with expected survival \< 72 hours.
4. Severe active bleeding requiring massive transfusion with ongoing hemodynamic instability.
5. Previously enrolled in this trial.
6. Investigator judges that sequential MAP titration carries unacceptable clinical risk.
Source: ClinicalTrials.gov (NCT07887854). StuddyBuddy aggregates publicly available trial information.