Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05225402

Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Septic Shock Hemodynamic Instability Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Vasoconstriction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre Hospital

Hvidovre, Copenhagen, 2665, Denmark

Location status: Recruiting

Location contact

Henrik Wolsted

CONTACT

[email protected]

21494485

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Suspected or documented infection
  • Need for vasopressors to maintain mean arterial blood pressure (MAP) ≥65 mmHg
  • Serum lactate levels >2 mmol/L
  • Norepinephrine infusion of > 0.2 mcg/kg/min

Exclusion criteria

  • Absolute contraindication for esophageal doppler or urinary catheter insertion as noted in the patients' charts.
  • Severe valvular pathology and cardiac arrhythmias resulting in severe hemodynamic instability.
  • Lithium treatment
  • Treatment with other vasopressor or inotropic drugs.

Treatment and study plan

Hemodynamic measurements during reduction in Norepinephrine and fluid boli.

Drug
  • 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.
  • 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.
  • 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%.
  • As in step 2, a stepwise increase in NE infusion rate to the baseline infusion level or the baseline BP.

Primary outcomes

  1. Preload responsiveness defined as stroke volume increase > 10%, measured by continuous arterial waveform analysis.

    Time frame: Through study completion, an average of 1 year

    The number of patients who were preload responsive after down-titration of NE.

Secondary outcomes

  1. Cardiac output response measured by lithium indicator dilution and Doppler ultrasound.

    Time frame: Through study completion, an average of 1 year

    The effect on cardiac output after fluid bolus and subsequent up-titration of NE to the pre-intervention blood pressure target.

  2. Microcirculation/perfusion measures during intervention.

    Time frame: Through study completion, an average of 1 year

    The effect of the intervention on measures of tissue perfusion. Different topical sites (Brain, Muscle, Finger, Urethra, Sublingual) by minimal- or noninvasive methods.

  3. CO measurement method

    Time frame: Through study completion, an average of 1 year

    Assess the correlation between indirect measurements of CO and lithium dilution measured CO during NE titration.

Study contacts

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

Henrik Wolsted, MD

CONTACT

[email protected]

+45 21 49 44 85

Nicolai Bang Foss, MD, DMsC

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Copenhagen University Hospital, Hvidovre

Other

Collaborators

  • University Hospital Bispebjerg and Frederiksberg

Registry information

Official study title

Effects of Norepinephrine on Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU Patients with Septic Shock

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2022
Registry last updated
Mar 7, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.