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O2 Consumption And CO2 Production After Hemodynamic Optimization In Shock

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07107724
Acronym
OxyCarDio
Enrollment
36
Registered
2025-08-06
Start date
2025-07-29
Completion date
2027-12-31
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability, Oxygen Consumption (V̇O2)

Brief 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.

Interventions

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.

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.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Change in VO2Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hourChange in VO2, measured via a dedicated ventilator after either fluid expansion or increase in vasopressors administration.

Secondary

MeasureTime frameDescription
Change in VCO2Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hourChange in VCO2, measured via a dedicated ventilator after either fluid expansion or increase in vasopressors administration.

Countries

Italy

Contacts

Primary ContactAntonio M Dell'Anna
antoniomaria.dellanna@policlinicogemelli.it+39 0630154490

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026