RecruitingNCT07107724

O2 Consumption And CO2 Production After Hemodynamic Optimization In Shock

Oxygen Consumption And Carbon Dioxide Production Following Hemodynamic Optimization In Shock: The OxyCarDio Study


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

36 participants

Start Date

Jul 29, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Hypotension (MAP< 65mmHg or sudden drop in MAP > 15 mmHg) and one of the following conditions:
  • Heart rate > 120 bpm
  • Urinary output < 0.5 ml/kg/h for at least two hours
  • Lactate > 2 mmol/L

Exclusion Criteria13

  • Urgent need for surgery
  • Urgent need for veno-arterial ECMO or severe hemodynamic instability
  • Consistent risk of imminent death
  • Severe ARDS or severe respiratory failure (p/F < 100 mmHg) and/or FiO2>0.8
  • Severe heart failure (NYHA 4 and/or EF<25%)
  • Need for intermittent or continuous renal replacement therapy (IRRT or CRRT)
  • Anemia defined as Hb<8 g/dL
  • VO2 variability < 5% throughout ten minutes of stabilization before procedure start
  • Intraabdominal hypertension, defined as intraabdominal pressure > 18 mmHg
  • Pregnancy
  • Withdrawal or refuse of informed consent
  • Terminal disease
  • Do-not-resuscitate order.

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Interventions

OTHERNoradrenalin

After inclusion, patients will be tested for fluid responsiveness. Pulse pressure variation (PPV) will be evaluated. In case of PPV\> 13% a fluid bolus of 500 mL of Lactated Ringer's will be administered in 10 minutes. If PPV\< 8% Norepinephrine will be administered or increased. If PPV is in the gray zone, a PLRT will be performed and if CO increases more than 10% a fluid bolus will be prescribed, otherwise norepinephrine increased.

OTHERFluid bolus

After inclusion, patients will be tested for fluid responsiveness. Pulse pressure variation (PPV) will be evaluated. In case of PPV\> 13% a fluid bolus of 500 mL of Lactated Ringer's will be administered in 10 minutes. If PPV\< 8% Norepinephrine will be administered or increased. If PPV is in the gray zone, a PLRT will be performed and if CO increases more than 10% a fluid bolus will be prescribed, otherwise norepinephrine increased.


Locations(1)

Policlinico Universitario Fondazione Agostino Gemelli IRCCS

Roma, Italy

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NCT07107724


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