O2 Consumption And CO2 Production After Hemodynamic Optimization In Shock

Recruiting

• Conditions: Hemodynamic Instability; Oxygen Consumption (V̇O2)

• Registration Number: NCT07107724
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-23
• Study Start: 2025-07-29
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Primary Completion: 2027-07
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Change in VCO2	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.

Trial Locations

Locations (1)

Policlinico Universitario Fondazione Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy