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Hemodynamic Effects of Norepinephrine Reduction on Critical Closing Pressure in Distributive Shock

Changes in Critical Closing Pressure and Derived Hemodynamic Parameters Following Norepinephrine Dose Reduction in Distributive Shock Patients: a Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07653659
Enrollment
30
Registered
2026-06-17
Start date
2025-09-01
Completion date
2027-09-01
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Distributive Shock, Hemodynamic Assessment

Keywords

Critical closing pressure, Tissue perfusion pressure, Vascular waterfall, Norepinephrine dose, Distributive shock

Brief summary

This study prospectively observes changes in critical closing pressure (Pcc) and derived hemodynamic parameters in mechanically ventilated distributive shock patients when clinically indicated norepinephrine dose reduction is performed by the attending physician. Pcc is measured before and 30 minutes after dose reduction using a stepwise inspiratory hold maneuver via PiCCO monitoring.

Detailed description

In distributive shock patients receiving norepinephrine with MAP maintained in the 75-85 mmHg range, attending physicians may reduce norepinephrine dose based on clinical judgment. This study observes hemodynamic changes associated with such reductions without any investigator-initiated intervention. Critical closing pressure (Pcc) and derived parameters including tissue perfusion pressure (TPP), mean systemic filling pressure analogue (Pmsf), and vascular waterfall (VW) are measured at baseline and 30 minutes after dose reduction, provided MAP variability is less than 5 mmHg. Pcc is derived from linear regression of simultaneously measured cardiac output (CO) and mean arterial pressure (MAP) during stepwise inspiratory hold maneuvers. Steady-state CO and MAP values are recorded during the final 3 seconds of 12-second inspiratory holds at plateau pressures of 5, 15, 25, and 35 cmH2O. The x-intercept of the CO-MAP regression line is taken as Pcc.

Interventions

OTHERNot applicable- observational study

Observation of hemodynamic parameters before and after clinically indicated norepinephrine dose reduction. No investigator-initiated intervention was performed.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adult distributive shock patients aged ≥18 years; 2. Receiving norepinephrine infusion with MAP in the 75-85 mmHg range; 3. PiCCO catheter in situ; 4. Under mechanical ventilation; 5. Clinically indicated norepinephrine dose reduction per attending physician judgment.

Exclusion criteria

1. Significant cardiac arrhythmia affecting CO measurement reliability; 2. Contraindication to airway plateau pressure maneuver; 3. Active titration of other vasoactive agents within 30 minutes prior to measurement; 4. Hemodynamic instability making it impossible to reduce norepinephrine dose.

Design outcomes

Primary

MeasureTime frameDescription
Change in critical closing pressure (Pcc, Unit: mmHg) before and after norepinephrine dose reductionBaseline and 30 minutes after norepinephrine dose reductionPcc is derived from linear regression of simultaneously measured cardiac output against mean arterial pressure during stepwise inspiratory hold maneuvers via PiCCO monitoring. The x-intercept of the regression line (at zero flow) represents Pcc. Measurement is performed at baseline and 30 minutes after norepinephrine dose reduction.
Change in tissue perfusion pressure (TPP, unit: mmHg) before and after norepinephrine dose reductionBaseline and 30 minutes after norepinephrine dose reductionTPP is calculated as the difference between mean arterial pressure (MAP) and critical closing pressure (Pcc): TPP = MAP minus Pcc, unit: mmHg

Secondary

MeasureTime frameDescription
Change in mean systemic filling pressure analogue (Pmsf, unit: mmHg) before and after norepinephrine dose reductionBaseline and 30 minutes after norepinephrine dose reductionPmsf is estimated as the x-intercept of the linear regression of cardiac output against central venous pressure (CVP), representing the venous pressure at zero flow.
Change in Vascular waterfall (VW, unit: mmHg) before and after norepinephrine dose reductionBaseline and 30 minutes after norepinephrine dose reductionVascular waterfall (VW) is calculated as Pcc minus Pmsf.
Change in capillary refill time (CRT, unit: seconds)Baseline and 30 minutes after norepinephrine dose reductionCapillary refill time is assessed by applying pressure to the fingertip for 5 seconds and measuring the time for color to return after release.

Countries

China

Contacts

CONTACTBin Du, Dr
sunyaliii@163.com86+15136289398

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026