Hemodynamic Measurements of Macrocirculatory and Perfusion Parameters in ICU

Recruiting

• Conditions: Hemodynamic Instability; Septic Shock; Vasoconstriction
• Interventions: Drug: Hemodynamic measurements during reduction in Norepinephrine and fluid boli.

• Registration Number: NCT05225402
• Lead Sponsor: Copenhagen University Hospital, Hvidovre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-02-04
• Study Start: 2022-03-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Septic Shock	Hemodynamic measurements during reduction in Norepinephrine and fluid boli.	Adult patients with septic shock, admitted to ICUs at Hvidovre and Bispebjerg Hospital, respectively. Sedated and mechanically ventilated adult patients (\>18 years).

Primary Outcome Measures

Name	Time	Method
Preload responsiveness defined as stroke volume increase > 10%, measured by continuous arterial waveform analysis.	Through study completion, an average of 1 year	The number of patients who were preload responsive after down-titration of NE.

Secondary Outcome Measures

Name	Time	Method
CO measurement method	Through study completion, an average of 1 year	Assess the correlation between indirect measurements of CO and lithium dilution measured CO during NE titration.
Cardiac output response measured by lithium indicator dilution and Doppler ultrasound.	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.
Microcirculation/perfusion measures during intervention.	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.

Trial Locations

Locations (1)

Hvidovre Hospital; 🇩🇰 Hvidovre, Copenhagen, Denmark