Menu
Recruiting NCT07107724

O2 Consumption And CO2 Production After Hemodynamic Optimization In Shock

— Observational Hemodynamic Instability Oxygen Consumption (V̇O2)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Noradrenalin, Fluid bolus.
Who it may be relevant to
Registry conditions: Hemodynamic Instability, Oxygen Consumption (V̇O2). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Noradrenalin
    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.
  • Other Fluid bolus
    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.

Primary outcome measures

  • Change in VO2 [Time frame: Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hour]
Secondary outcome measures (1)
  • Change in VCO2 [Time frame: Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hour]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Policlinico Universitario Fondazione Agostino Gemelli IRCCS — Roma

Identifiers

NCT: NCT07107724 · 7655

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗