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Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU

NCT05225402 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2025-03-07

No results posted yet for this study

Summary

In septic shock there is growing evidence of a state of hemodynamic "disconnection" with seemingly adequate macrocirculatory values despite actual microcirculation failing to meet cellular demand. Norepinephrine (NE) is recommended as first choice vasoactive agent for the treatment of septic shock. However, the dynamic effects of NE on macro- and microcirculation and perfusion parameters has not been described in detail in the context of septic shock, precluding rational individualized titration of NE and fluids, as recommended recently. In the present prospective observational multicenter study in adult septic shock patients, we intend to explore the effects of NE on preload dependency and tissue perfusion by evaluating the correlation and potential discrepancies between macro- and microcirculation both during titration of NE and after fluid resuscitation. The conclusions drawn from our study will contribute to the physiological knowledge necessary for establishing individualized evidence-based bedside management of hemodynamics in the setting of septic shock.

Conditions

  • Septic Shock
  • Hemodynamic Instability
  • Vasoconstriction

Interventions

DRUG

Hemodynamic measurements during reduction in Norepinephrine and fluid boli.

1. Extended monitoring equipment will be connected to the patient. Clinical and biochemical parameters will be collected for a baseline before the next step. A Safety check will be performed to ensure correct patient data, correct equipment function and safety measures are meet. A passive leg raise test will be performed to predict fluid responsiveness, in case of a positive test, a fluid challenge will be administered. 2. A stepwise reduction of the NE infusion rate from baseline while monitoring stroke volume (SV) to elucidate changes in SV and potential preloadresponsiveness. The reduction will occur in steps of 3-5 minute until either discontinuation of the norepinephrine infusion, a 50% reduction in SV or MAP\<40. 3. While maintaining the NE infusion rate from the previous step 2, a fluid challenge will be administrated, until additional fluid does not increase SV\>10%. 4. As in step 2, a stepwise increase in NE infusion rate to the baseline infusion level or the baseline BP.

Sponsors & Collaborators

  • University Hospital Bispebjerg and Frederiksberg

    collaborator OTHER

  • Copenhagen University Hospital, Hvidovre

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2025-07-30
Completion
2025-12-30
FDA Drug
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05225402 on ClinicalTrials.gov