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NCT Number: NCT07107724

O2 Consumption And CO2 Production After Hemodynamic Optimization In Shock

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.

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Key information

Conditions

Hemodynamic Instability Oxygen Consumption (V̇O2)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Policlinico Universitario Fondazione Agostino Gemelli IRCCS

Roma, 00168, Italy

Location status: Recruiting

Location contact

Antonio M Dell'Anna

CONTACT

[email protected]

+39 0630154490

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

  • 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.

Treatment and study plan

Noradrenalin

Other

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.

Fluid bolus

Other

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.

Primary outcomes

  1. Change in VO2

    Time frame: Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hour

    Change in VO2, measured via a dedicated ventilator after either fluid expansion or increase in vasopressors administration.

Secondary outcomes

  1. Change in VCO2

    Time frame: Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hour

    Change in VCO2, measured via a dedicated ventilator after either fluid expansion or increase in vasopressors administration.

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio M Dell'Anna

CONTACT

[email protected]

+39 0630154490

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: OxyCarDio

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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