Clinical trial NCT05225402: Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU
Official title: Effects of Norepinephrine on Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU Patients with Septic Shock
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Septic Shock
Hemodynamic Instability
Vasoconstriction
Keywords: Septic Shock
Norepinephrine
Hemodynamic
Microcirculation
Intensive Care
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: University Hospital Bispebjerg and Frederiksberg
First posted: 2022-02-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 45 adult patients with septic shock according to inclusion criteria admitted to ICUs at Hvidovre and Bispebjerg Hospital, respectively.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Preload responsiveness defined as stroke volume increase > 10%, measured by continuous arterial waveform analysis.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Cardiac output response measured by lithium indicator dilution and Doppler ultrasound.
timeFrame: Through study completion, an average of 1 year
measure: Microcirculation/perfusion measures during intervention.
timeFrame: Through study completion, an average of 1 year
measure: CO measurement method
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: Copenhagen
Study officials:
References: