Actively Recruiting

Age: 18Years +
All Genders
NCT07107724

O2 Consumption And CO2 Production After Hemodynamic Optimization In Shock

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-08-06

36

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this prospective observational study is to analyse change in VO2 and VCO2 measured via a dedicated ventilator after hemodynamic optimization maneuvers in adult patients admitted to the ICU with any sign of shock. The main questions it aims to answer are: 1. Do common maneuvers for hemodynamic optimization (fluid bolus and/or vasopressor administration) have any impact on tissue perfusion in terms of oxygen consumption (VO2) and carbon dioxide production (VCO2) measured by a dedicated ventilator? 2. Are the values measured by exhaled gas comparable to those calculated by the measurement of dissolved veno-arterial gas? Participants enrolled in the study will receive advanced hemodynamic monitoring with MostCare Up (Vygon ®) and their hemodynamic instability will be managed according to most recent guidelines and based on clinical decision of treating physicians.

CONDITIONS

Official Title

O2 Consumption And CO2 Production After Hemodynamic Optimization In Shock

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with hypotension defined as mean arterial pressure (MAP) less than 65 mmHg or a sudden drop in MAP greater than 15 mmHg
  • Presence of at least one of the following: heart rate over 120 bpm, urinary output less than 0.5 ml/kg/h for at least two hours, or lactate level above 2 mmol/L
Not Eligible

You will not qualify if you...

  • Urgent need for surgery
  • Urgent need for veno-arterial ECMO or severe hemodynamic instability
  • High risk of imminent death
  • Severe acute respiratory distress syndrome or respiratory failure with p/F ratio below 100 mmHg and/or FiO2 greater than 0.8
  • Severe heart failure (NYHA class 4 or ejection fraction below 25%)
  • Need for intermittent or continuous renal replacement therapy
  • Anemia with hemoglobin less than 8 g/dL
  • Oxygen consumption variability less than 5% during ten minutes before procedure
  • Intraabdominal hypertension with pressure above 18 mmHg
  • Pregnancy
  • Withdrawal or refusal of informed consent
  • Terminal illness
  • Do-not-resuscitate order

AI-Screening

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Trial Site Locations

Total: 1 location

1

Policlinico Universitario Fondazione Agostino Gemelli IRCCS

Roma, Italy, 00168

Actively Recruiting

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Research Team

A

Antonio M Dell'Anna

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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