An interventional study of Ascending MAP titration sequence and Descending MAP titration sequence in Sepsis, sponsored by Peking Union Medical College Hospital. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
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.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's planned enrollment of 24 is below the median of 105 across 918 interventional studies indexed under Sepsis.
Browse Sepsis studies →Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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
【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.
【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.
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.
Time frame: During intervention
Perfusion Gain Efficiency (PGE) at low and high MAP intervals
Mean Arterial Pressure (MAP) is the primary hemodynamic target. Tissue Perfusion Pressure (TPP) is calculated as MAP minus microvascular critical closing pressure (Pcc). Perfusion Gain Efficiency (PGE) is calculated as the slope of linear regression between MAP and TPP within each MAP interval (60-65, 65-70, 70-75 mmHg), reflecting the efficiency of MAP elevation in improving tissue perfusion. PGE \> 1 indicates efficient perfusion conversion; PGE ≤ 0 indicates plateau effect.
Time frame: During intervention
Coefficient of variation of microvascular critical closing pressure (Pcc) across three MAP target intervals
Mean Arterial Pressure (MAP) is the primary hemodynamic target. Tissue Perfusion Pressure (TPP) is calculated as MAP minus microvascular critical closing pressure (Pcc). Intra-individual variability of Pcc measured at 60-65, 65-70, 70-75 mmHg MAP stages, expressed as coefficient of variation (CV).
Time frame: During intervention
Automated capillary refill time (aCRT) at three MAP target levels
Mean Arterial Pressure (MAP) is the primary hemodynamic target. Standardized objective automated capillary refill time (aCRT) is measured via Mindray V700 monitor peripheral perfusion module at each stable MAP stage.
Time frame: During intervention
Inflection point of MAP-TPP dose-response curve
Mean Arterial Pressure (MAP) is the primary hemodynamic target. Tissue Perfusion Pressure (TPP) is calculated as MAP minus microvascular critical closing pressure (Pcc). Segmented linear regression to identify the MAP threshold where TPP perfusion gain plateaus or declines across 60-65, 65-70, 70-75 mmHg intervals.
Time frame: During intervention
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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