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

Overview

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.

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 monitori

Primary outcome measures

• Preload responsiveness defined as stroke volume increase > 10%, measured by continuous arterial waveform analysis. [Time frame: Through study completion, an average of 1 year]

Secondary outcome measures (3)

• Cardiac output response measured by lithium indicator dilution and Doppler ultrasound. [Time frame: Through study completion, an average of 1 year]
• Microcirculation/perfusion measures during intervention. [Time frame: Through study completion, an average of 1 year]
• CO measurement method [Time frame: Through study completion, an average of 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Denmark · 1 center

• Hvidovre Hospital — Hvidovre

Identifiers

NCT: NCT05225402 · HW-NA-Fluid-Measurements

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗