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Clinical Trials in Italy / NCT07107724
Recruiting Observational

O2 Consumption And CO2 Production After Hemodynamic Optimization In Shock

NCT07107724 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2025-07-29
Last updated
2025-08-06

Condition(s) studied

Hemodynamic InstabilityOxygen Consumption (V̇O2)

Investigational drug(s) / intervention(s)

NoradrenalinFluid bolus

Noradrenalin: 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: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in VO2 — 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.

Trial sites (1)

FacilityCityRegionStatus
Policlinico Universitario Fondazione Agostino Gemelli IRCCS Roma Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07107724 on ClinicalTrials.gov ↗ ← All trials in Italy