Hemodynamic InstabilityHEART-CORENCT03113435
Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach
A study testing Oxygen consumption optimization in people with Hemodynamic Instability, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This study compares the actual standard of care with a new protocol to guide hemodynamic optimization during major abdominal surgery, which is more tailored on patient real needs. During general anesthesia metabolic needs of the body are markedly reduced and increase in CO may not be necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Oxygen consumption optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2018to 31 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- patients aged > 18 years
- acquisition of written informed consent
- Major abdominal surgery (major gastrointestinal surgery: DCP, gastrectomy, Miles, emicolectomy; gynecologic surgery: oncologic surgery) Surgery times ≥ 3 hours
Who cannot join
- Absolute contraindication to CVC placement
- pregnant women
- hepatic surgery
- laparoscopic surgery
- Major vascular surgery
- Dialysis treatment and kidney transplant surgery
- Severe heart failure (EF ≤ 35%)
- Emergency surgery
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
Fondazione Policlinico A. Gemelli IRCCS
Roma, 00168
Antonio M Dell'Anna, MD, +390630154490, antoniomaria.dellanna@policlinicogemelli.it
About this study
Official title: Patient Management During Major Abdominal Surgery: the Impact of a Hemodynamic Approach Oriented to Oxygen Consumption Optimization Compared to Standard Approach Targeting Preload-dependency and a Clinically-guided Strategy
This study compares the actual standard of care with a new protocol to guide hemodynamic optimization during major abdominal surgery, which is more tailored on patient real needs. During general anesthesia metabolic needs of the body are markedly reduced and increase in CO may not be necessary. In addition, excessive fluid administration has been related to worse post-operative outcomes. We divide patients into three groups: the standard treatment group, the NICE protocol group and the intervention group. In this group we use the v-aCO2/CaO2-CvO2 as marker of tissue ability to increase their oxygen consumption in response to increased O2 delivery, and based on this index the administration of fluid. The principal aim is to optimize functional hemodynamics in order to reduce the fluid balance at the end of the surgery.
- Conditions
- Hemodynamic Instability
- Being tested
- Oxygen consumption optimization
- Keywords
- CO2 gap, oxygen consumption, Stroke volume optimization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen consumption optimizationOther
hemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | In this group standard care will be provided to patients undergoing major abdominal surgery, regarding hemodynamic optimization |
| NICE group | Active comparator | In this arm patients will be treated according to stroke volume optimization described in NICE program Receives: Other: Oxygen consumption optimization |
| Oxygen consumption group | Experimental | In this arm patients will receive hemodynamic optimization based on their oxygen consumption need Receives: Other: Oxygen consumption optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative fluid balance
Perioperative fluid balance
Measured: surgery
Secondary outcomes (3)
Survival at 28 days
Patients who survived at 28 days
Measured: 28 days after surgery
Survival at hospital discharge
Patient who survived at hospital discharge
Measured: 1 day (Hospital discharge)
Post-operative complication
Increase in TnI, need for mechanical ventilation, infection, ICU admission, anastomotic leak, bleeding, AKI
Measured: 1 day (Hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start1 Jun 2018
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Flavia Torrini, Alessandra Bisanti, Eleonora Filipponi, Domenica Luca Grieco, Antonelli, Massimo, M.D., Liliana Sollazzi, Valter Perilli, Andrea Russo, Pierpaolo Ciocchetti
- Responsible party
- Principal investigator, Antonio Maria Dell'Anna, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Antonio M Dell'Anna, MD, Principal investigator, Fondazione Policlinico Universitario A. Gemelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113435
- Sponsor's protocol ID
- 1305
- Acronym
- HEART-CORE
- Status last verified
- Mar 2025
- First submitted
- 10 Apr 2017
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Management During Major Abdominal Surgery: the Impact of a Hemodynamic Approach Oriented to Oxygen Consumption Optimization Compared to Standard Approach Targeting Preload-dependency and a Clinically-guided Strategy
- ClinicalTrials.gov ID
- NCT03113435
- Acronym / sponsor ID
- HEART-CORE / 1305
- Conditions
- Hemodynamic Instability
- Keywords
- CO2 gap, oxygen consumption, Stroke volume optimization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Flavia Torrini, Alessandra Bisanti, Eleonora Filipponi, Domenica Luca Grieco, Antonelli, Massimo, M.D., Liliana Sollazzi, Valter Perilli, Andrea Russo, Pierpaolo Ciocchetti
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Apr 2017 (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.
This study compares the actual standard of care with a new protocol to guide hemodynamic optimization during major abdominal surgery, which is more tailored on patient real needs. During general anesthesia metabolic needs of the body are markedly reduced and increase in CO may not be necessary. In addition, excessive fluid administration has been related to worse post-operative outcomes. We divide patients into three groups: the standard treatment group, the NICE protocol group and the intervention group. In this group we use the v-aCO2/CaO2-CvO2 as marker of tissue ability to increase their oxygen consumption in response to increased O2 delivery, and based on this index the administration of fluid. The principal aim is to optimize functional hemodynamics in order to reduce the fluid balance at the end of the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –In this group standard care will be provided to patients undergoing major abdominal surgery, regarding hemodynamic optimization |
| NICE group | Active comparator | Other: Oxygen consumption optimizationIn this arm patients will be treated according to stroke volume optimization described in NICE program |
| Oxygen consumption group | Experimental | Other: Oxygen consumption optimizationIn this arm patients will receive hemodynamic optimization based on their oxygen consumption need |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged > 18 years
- acquisition of written informed consent
- Major abdominal surgery (major gastrointestinal surgery: DCP, gastrectomy, Miles, emicolectomy; gynecologic surgery: oncologic surgery) Surgery times ≥ 3 hours
Key exclusion criteria (8 listed)
- Absolute contraindication to CVC placement
- pregnant women
- hepatic surgery
- laparoscopic surgery
- Major vascular surgery
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 |
|---|---|---|
| Oxygen consumption optimizationhemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio | Other | NICE group, Oxygen consumption group |
Primary outcome
Perioperative fluid balance
Time frame: surgery
Perioperative fluid balance
3 secondary outcomes
Survival at 28 days
Time frame: 28 days after surgery
Survival at hospital discharge
Time frame: 1 day (Hospital discharge)
Post-operative complication
Time frame: 1 day (Hospital discharge)
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 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Antonio M Dell'Anna, MD principal investigator
Fondazione Policlinico Universitario A. Gemelli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen consumption optimization in people with Hemodynamic Instability, 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 3 inclusion and 8 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 11 Mar 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, MD (+390630154490, anthosdel@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative fluid balance (time frame: surgery). 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 11 Mar 2025.