O2 Consumption And CO2 Production After Hemodynamic Optimization In Shock
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Heart rate > 120 bpm
Urinary output < 0.5 ml/kg/h for at least two hours
Lactate > 2 mmol/L
Disqualifiers
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
Trial population
Patients admitted to the ICU with signs of hemodynamic instability
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Noradrenalin
Other interventionAfter 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 interventionAfter 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Change in VO2
Change in VO2, measured via a dedicated ventilator after either fluid expansion or increase in vasopressors administration.
Time frame
Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hourSecondary outcomes
1
Change in VCO2
Change in VCO2, measured via a dedicated ventilator after either fluid expansion or increase in vasopressors administration.
Time frame
Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hourSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov