Hemodynamic InstabilityOxyCarDioNCT07107724
O2 Consumption And CO2 Production After Hemodynamic Optimization In Shock
An observational study of Hemodynamic Instability and Oxygen Consumption (V̇O2), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability, Oxygen Consumption (V̇O2)
- What is being tested?
- Noradrenalin and Fluid bolus
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jul 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU with signs of hemodynamic instability
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Universitario Fondazione Agostino Gemelli IRCCS
Roma, 00168
Antonio M Dell'Anna, +39 0630154490, antoniomaria.dellanna@policlinicogemelli.it
About this study
Official title: Oxygen Consumption And Carbon Dioxide Production Following Hemodynamic Optimization In Shock: The OxyCarDio Study
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:
Read more
- 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.
- Conditions
- Hemodynamic Instability, Oxygen Consumption (V̇O2)
- Being tested
- Noradrenalin, Fluid bolus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NoradrenalinOther
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.
Fluid bolusOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2
Change in VO2, measured via a dedicated ventilator after either fluid expansion or increase in vasopressors administration.
Measured: Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hour
Secondary outcomes (1)
Change in VCO2
Change in VCO2, measured via a dedicated ventilator after either fluid expansion or increase in vasopressors administration.
Measured: Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start29 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Maria Dell'Anna, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107724
- Sponsor's protocol ID
- 7655
- Acronym
- OxyCarDio
- Status last verified
- Jul 2025
- First submitted
- 23 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Consumption And Carbon Dioxide Production Following Hemodynamic Optimization In Shock: The OxyCarDio Study
- ClinicalTrials.gov ID
- NCT07107724
- Acronym / sponsor ID
- OxyCarDio / 7655
- Conditions
- Hemodynamic Instability, Oxygen Consumption (V̇O2)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU with signs of hemodynamic instability
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NoradrenalinAfter 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 bolusAfter 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 | – |
Primary outcome
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.
1 secondary outcome
Change in VCO2
Time frame: Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Instability and Oxygen Consumption (V̇O2), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio M Dell'Anna (+39 0630154490, antoniomaria.dellanna@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VO2 (time frame: Two minutes after the end of fluid bolus infusion or vasopressor increase, and every 10 minutes for one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.