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

12. juni 2026 opdateret af: Bin Du, Peking Union Medical College Hospital

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100730
        • Rekruttering
        • Peking Union Medical College Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult distributive shock patients receiving invasive mechanical ventilation and norepinephrine treatment

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Distributive shock patients undergoing norepinephrine dose reduction
Mechanically ventilated distributive shock patients in whom the attending physician clinically indicated norepinephrine dose reduction, with MAP transitioning from the 75-85 mmHg range to the 65-75 mmHg range.
Andet: Not applicable- observational study
Observation of hemodynamic parameters before and after clinically indicated norepinephrine dose reduction. No investigator-initiated intervention was performed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in critical closing pressure (Pcc, Unit: mmHg) before and after norepinephrine dose reduction
Tidsramme: 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.
Baseline and 30 minutes after norepinephrine dose reduction
Change in tissue perfusion pressure (TPP, unit: mmHg) before and after norepinephrine dose reduction
Tidsramme: 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
Baseline and 30 minutes after norepinephrine dose reduction

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in mean systemic filling pressure analogue (Pmsf, unit: mmHg) before and after norepinephrine dose reduction
Tidsramme: 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.
Baseline and 30 minutes after norepinephrine dose reduction
Change in Vascular waterfall (VW, unit: mmHg) before and after norepinephrine dose reduction
Tidsramme: Baseline and 30 minutes after norepinephrine dose reduction
Vascular waterfall (VW) is calculated as Pcc minus Pmsf.
Baseline and 30 minutes after norepinephrine dose reduction
Change in capillary refill time (CRT, unit: seconds）
Tidsramme: 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.
Baseline and 30 minutes after norepinephrine dose reduction

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking Union Medical College Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2025

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

12. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • pumch-micu202606

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INGEN

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