Oxygen Consumption And Carbon Dioxide Production Following Hemodynamic Optimization In Shock: The OxyCarDio Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in VO2
Study Overview
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:
- 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?
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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
- Change in VCO2(Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hour)
Investigators
Antonio Maria Dell'Anna
Doctor, MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS