NCT07107724 O2 Consumption And CO2 Production After Hemodynamic Optimization In Shock
| NCT ID | NCT07107724 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Hemodynamic Instability |
| Study Type | OBSERVATIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-07-29 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 36 participants in total. It began in 2025-07-29 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07107724 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemodynamic Instability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07107724 currently recruiting?
Yes, NCT07107724 is actively recruiting participants. Contact the research team at antoniomaria.dellanna@policlinicogemelli.it for enrollment information.
Where is the NCT07107724 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07107724 clinical trial?
NCT07107724 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 36 participants.