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

NCT07887854 | Not Yet Recruiting

• 1 other identifier: ICU-PEDE trial
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sepsis

Keywords

Mean Arterial Pressure; Tissue Perfusion Pressure; Vasopressor; Peripheral Perfusion; Elderly

Outcome Measures

Primary Outcomes (1)

• Mean difference in Tissue Perfusion Pressure (TPP) between MAP target 60-65 mmHg and 65-70 mmHg

  Mean Arterial Pressure (MAP) is the primary hemodynamic target. Tissue Perfusion Pressure (TPP) is calculated as MAP minus microvascular critical closing pressure (Pcc). Primary non-inferiority endpoint: ΔTPP = Mean TPP at 60-65 mmHg minus mean TPP at 65-70 mmHg (unit: mmHg). Non-inferiority margin set at -4 mmHg; non-inferiority is confirmed if the lower bound of one-sided 95% CI of ΔTPP ≥ -4 mmHg. TPP is calculated as MAP minus microvascular critical closing pressure (Pcc) using routine invasive arterial waveform data, no extra invasive procedures added.

  During intervention

Secondary Outcomes (3)

• Perfusion Gain Efficiency (PGE) at low and high MAP intervals

  During intervention

• Coefficient of variation of microvascular critical closing pressure (Pcc) across three MAP target intervals

  During intervention

• Automated capillary refill time (aCRT) at three MAP target levels

  During intervention

Other Outcomes (1)

• Inflection point of MAP-TPP dose-response curve

  During intervention

Study Arms (2)

Ascending MAP titration sequence

EXPERIMENTAL

Sequential target MAP titration from 60-65 mmHg → 65-70 mmHg → 70-75 mmHg. Each MAP stage lasts for a fixed observation period.

Other: Ascending MAP titration sequence

Descending MAP titration sequence

EXPERIMENTAL

Sequential target MAP titration from 70-75 mmHg → 65-70 mmHg → 60-65 mmHg. Each MAP stage lasts for a fixed observation period.

Other: Descending MAP titration sequence

Interventions

Descending MAP titration sequence OTHER

【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.

Descending MAP titration sequence

Ascending MAP titration sequence OTHER

【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.

Ascending MAP titration sequence

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Elderly patients (≥65 years) admitted to ICU with septic shock requiring invasive arterial blood pressure monitoring and vasopressor support.
• Clinically indicated target mean arterial pressure (MAP) range covering 60-75 mmHg.
• Expected duration of stable hemodynamic status ≥ 150 minutes to complete the crossover titration protocol.
• Attending intensivist agrees to participate; written informed consent obtained from patient or legally authorized representative.

You may not qualify if:

• Age \< 65 years.
• Severe aortic stenosis, aortic dissection, or uncontrolled intracranial hypertension requiring fixed high MAP target.
• Known irreversible terminal condition with expected survival \< 72 hours.
• Severe active bleeding requiring massive transfusion with ongoing hemodynamic instability.
• Previously enrolled in this trial.
• Investigator judges that sequential MAP titration carries unacceptable clinical risk.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yuankai Zhou, Dr

CONTACT

+86-10-69152300; zhouyuankai@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to two sequence groups. Group 1 receives ascending MAP titration (60-65 mmHg → 65-70 mmHg →70-75 mmHg). Group 2 receives descending MAP titration (70-75 mmHg → 65-70 mmHg →60-65 mmHg). Every subject completes all three MAP target stages within one observation period, forming a within-subject crossover comparison.

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share