O2 Consumption And CO2 Production After Hemodynamic Optimization In Shock

NCT07107724 | Recruiting

• 1 other identifier: 7655
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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. 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. 2.Are the values measured by exhaled gas comparable to those calculated by the measurement of dissolved veno-arterial gas?

Conditions

Hemodynamic Instability; Oxygen Consumption (V̇O2)

Outcome Measures

Primary Outcomes (1)

• Change in VO2

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

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

Secondary Outcomes (1)

• Change in VCO2

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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the ICU with signs of hemodynamic instability

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Policlinico Universitario Fondazione Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Central Study Contacts

Antonio M Dell'Anna

CONTACT

+39 0630154490; antoniomaria.dellanna@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, MD

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 6, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

IT (1)