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NCT Number: NCT07653659

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Not applicable- observational study

Other

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

Primary outcomes

  1. Change in critical closing pressure (Pcc, Unit: mmHg) before and after norepinephrine dose reduction

    Time frame: Baseline and 30 minutes after norepinephrine dose reduction

    Pcc 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.

  2. Change in tissue perfusion pressure (TPP, unit: mmHg) before and after norepinephrine dose reduction

    Time frame: Baseline and 30 minutes after norepinephrine dose reduction

    TPP is calculated as the difference between mean arterial pressure (MAP) and critical closing pressure (Pcc): TPP = MAP minus Pcc, unit: mmHg

Secondary outcomes

  1. Change in mean systemic filling pressure analogue (Pmsf, unit: mmHg) before and after norepinephrine dose reduction

    Time frame: Baseline and 30 minutes after norepinephrine dose reduction

    Pmsf 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.

  2. Change in Vascular waterfall (VW, unit: mmHg) before and after norepinephrine dose reduction

    Time frame: Baseline and 30 minutes after norepinephrine dose reduction

    Vascular waterfall (VW) is calculated as Pcc minus Pmsf.

  3. Change in capillary refill time (CRT, unit: seconds)

    Time frame: Baseline and 30 minutes after norepinephrine dose reduction

    Capillary refill time is assessed by applying pressure to the fingertip for 5 seconds and measuring the time for color to return after release.

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Du, Dr

CONTACT

[email protected]

86+15136289398

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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