Oxygen use and carbon dioxide production after stabilizing blood flow in shock
Oxygen Consumption And Carbon Dioxide Production Following Hemodynamic Optimization In Shock: The OxyCarDio Study
This project will see if giving fluids or norepinephrine to adults in the ICU with shock changes how much oxygen their bodies use and how much carbon dioxide they make, measured from the ventilator and compared with blood gas calculations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT07107724 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study in adult ICU patients with signs of shock who receive standard hemodynamic optimization such as fluid boluses or vasopressors. VO2 and VCO2 will be measured continuously using a dedicated ventilator-based gas monitor and compared with values calculated from veno-arterial dissolved gas measurements. Patients will also receive advanced hemodynamic monitoring with the MostCare Up device and clinical management will follow current guidelines and treating physicians' decisions. The study aims to describe immediate changes in exhaled gas metrics after common resuscitation maneuvers and to test agreement between exhaled and blood-based measurements.
Who should consider this trial
Good fit: Mechanically ventilated adults in the ICU with hypotension and signs of hypoperfusion (for example low urine output, high lactate, or tachycardia) who are candidates for fluid bolus or vasopressor adjustment are ideal candidates.
Not a fit: Patients with severe respiratory failure or ARDS, those on or needing veno-arterial ECMO or continuous renal replacement therapy, imminently dying patients, pregnant patients, or those with do-not-resuscitate orders are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive, bedside way to track tissue oxygen use and guide resuscitation in ventilated patients with shock.
How similar studies have performed: Some prior studies have shown feasibility of measuring VO2 and VCO2 from exhaled gas in ventilated patients, but direct comparison with veno-arterial dissolved gas and response to hemodynamic maneuvers remains limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Roma
- Policlinico Universitario Fondazione Agostino Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Antonio M Dell'Anna
- Email: antoniomaria.dellanna@policlinicogemelli.it
- Phone: +39 0630154490
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.