SepsisNCT07887854
Perfusion Efficiency-Guided MAP De-escalation in Elderly Septic Shock
A study testing Ascending MAP titration sequence and Descending MAP titration sequence in people with Sepsis, run by Peking Union Medical College Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Ascending MAP titration sequence and Descending MAP titration sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Perfusion Efficiency-Guided MAP De-escalation in the Maintenance Phase of Elderly Septic Shock: A Randomized Crossover Non-Inferiority Trial
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
- Being tested
- Ascending MAP titration sequence, Descending MAP titration sequence
- Keywords
- Mean Arterial Pressure, Tissue Perfusion Pressure, Vasopressor, Peripheral Perfusion, Elderly
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascending MAP titration sequenceOther
【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 sequenceOther
【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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Descending MAP titration sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During intervention
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: During intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887854
- Sponsor's protocol ID
- ICU-PEDE trial
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No