Perioperative/Postoperative ComplicationsNCT04053595
Estimated Oxygen Extraction Versus Dynamic Parameters for Perioperative Hemodynamic Optimization
A study testing Dynamic parameters of fluid responsiveness protocol and Estimated oxygen extraction protocol in people with Perioperative/Postoperative Complications and Morality, run by Università Politecnica delle Marche at 1 site in Italy.
Trial summary
The aim of the study is to evaluate the complications rate of high risk patients undergoing non-cardiac surgery that receive two different protocols of hemodynamic optimization. A group of patients receive a protocol based on dynamic parameters of fluid responsiveness; the other group of patients receive a protocol… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative/Postoperative Complications, Morality
- What is being tested?
- Dynamic parameters of fluid responsiveness protocol and Estimated oxygen extraction protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 undergoing general anesthesia and mechanical ventilation for elective major open abdominal surgery (gastrointestinal, urologic, gynecologic and vascular surgery)
- expected duration of surgical procedure higher than 120 minutes
- ASA II-III-IV
- planned postoperative ICU/HDU admission
Who cannot join
- <18 years old
- pregnancy
- arrhythmia
- arterial curve alteration (resonance, damping) not solvable
- palliative surgical procedures
- denial of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimated Oxygen Extraction Versus Dynamic Parameters for Perioperative Hemodynamic Optimization of Patients Undergoing Non-cardiac Surgery: a Non-inferiority Randomized Controlled Trial
The aim of the study is to evaluate the complications rate of high risk patients undergoing non-cardiac surgery that receive two different protocols of hemodynamic optimization. A group of patients receive a protocol based on dynamic parameters of fluid responsiveness; the other group of patients receive a protocol based of the optimization of oxygen extraction.
The hypothesis is that a perioperative hemodynamic optimization protocol based on oxygen extraction is not inferior to a protocol based on dynamic parameters of fluid responsiveness considering the complication rate developed postoperatively.
Read the detailed description
Any surgical intervention is a trauma for the organism and a stress response is activated to cope the external insult. This stress response is responsible of an increase in oxygen consumption. If patient is not able to overcome the deficit in oxygen consumption (VO2) during the first hours postoperatively, he/she will go toward complications (in case of delay to meet metabolic demand) or death (in case of persistent VO2 deficit). Therefore, several protocols have been developed to optimise haemodynamic parameters with the aim to reduce tissue hypoperfusion coming from maldistribution or inadequate perfusion and meet the increased metabolic need as soon as possible.
Every patient that probably will not be able to face the surgical stress himself might benefit from modulation of haemodynamic parameters. Actually, goal directed therapy (GDT) is able to improve survival only in high-risk surgical patients. Instead, the reduction of complications rate has been shown also in intermediate-risk population.
Originally, hemodynamic optimisation protocols were developed to reach supranormal value for cardiac output (CO), oxygen delivery (DO2) and VO2. Based on the concept that oxygen extraction rate (O2ER) reflects the balance between DO2 and VO2, a GDT protocol based on O2ER estimation (O2ERe) calculated as (SaO2-ScvO2)/SaO2 has been proposed showing a significantly lower number of organ failure postoperatively compared with control group.
The major determinants of DO2 are cardiac output (CO), haemoglobin level (Hb) and arterial oxygen saturation (SaO2).
An inadequate CO may be optimised using fluids as first line therapy and then inotropes.
In mechanically ventilated patients, heart-lung interaction is useful to recognise in which portion of the Frank-Starling curve the heart of the patient is working and then if CO is able to rise after fluid administration aimed to increase preload. Several parameters based on mini-invasive monitor systems are available to assess fluid responsiveness such as pulse pressure variation (PPV) and stroke volume variation (SVV).
- Being tested
- Dynamic parameters of fluid responsiveness protocol, Estimated oxygen extraction protocol
- Keywords
- Peri-operative goal-directed therapy, Hemodynamic optimization, Postoperative complications, Mortality
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic parameters of fluid responsiveness protocolDiagnostic test
Dynamic parameter of fluid responsiveness (pulse pressure variation/stroke volume variation) are used to optimize hemodynamics intraoperatively and during the first 6 hours postoperatively when appropriate. A cutoff of 12% is used to predict an increase of stroke volume >10% after fluid administration.
Estimated oxygen extraction protocolDiagnostic test
Oxygen extraction is estimated by the difference of arterial oxygen saturation and central venous oxygen saturation divided by arterial oxygen saturation. A cutoff of 27% is used as a marker of inadequate tissue perfusion requiring hemodynamic optimization.
| Study group | Role | What they receive |
|---|---|---|
| Estimated Oxygen Extraction | Experimental | Not described Receives: Diagnostic Test: Estimated oxygen extraction protocol |
| Dynamic Parameters | Active comparator | Not described Receives: Diagnostic Test: Dynamic parameters of fluid responsiveness protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications rate
Evaluate the difference of postoperative complications rate between the two groups
Measured: From date of randomization until the date of hospital discharge assessed up to 90 days
Secondary outcomes (5)
Fluid administered
Evaluate the difference of total amount of fluids administered during the perioperative period between the two groups
Measured: Immediately after the surgery, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days
Fluid balance
Evaluate the difference of fluid balance (difference between fluid administered and fluid loss) during postoperative period between the two groups
Measured: Immediately after the surgery, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days
Vasopressor/inopropic drugs
Evaluate the difference in needs of vasopressor/inotropic drugs (reporting mean dosage used) between the two groups
Measured: Immediately after the, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days
Hospital length of stay
Evaluate the difference of total number of days of hospital stay between the two groups
Measured: From date of randomization until the date of hospital discharge or death from any cause assessed up to 90 days
Mortality at day 28
Evaluate the difference of mortality rate at day 28 between the two groups
Measured: Day 28 from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study startJun 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative/Postoperative ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Politecnica delle Marche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abele Donati, MD, Università Politecnica delle Marche
- Investigators
- Abele Donati, MD, PhD, Principal investigator, Università Politecnica delle Marche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053595
- Sponsor's protocol ID
- CLRZ01-19
- Status last verified
- Mar 2020
- First submitted
- 11 Jun 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carsetti A, Amici M, Bernacconi T, Brancaleoni P, Cerutti E, Chiarello M, Cingolani D, Cola L, Corsi D, Forlini G, Giampieri M, Iuorio S, Principi T, Tappata G, Tempesta M, Adrario E, Donati A. Estimated oxygen extraction versus dynamic parameters of fluid-responsiveness for perioperative hemodynamic optimization of patients undergoing non-cardiac surgery: a non-inferiority randomized controlled trial. BMC Anesthesiol. 2020 Apr 18;20(1):87. doi: 10.1186/s12871-020-01011-z.
PubMed 32305061
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimated Oxygen Extraction Versus Dynamic Parameters for Perioperative Hemodynamic Optimization of Patients Undergoing Non-cardiac Surgery: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04053595
- Acronym / sponsor ID
- CLRZ01-19
- Keywords
- Peri-operative goal-directed therapy, Hemodynamic optimization, Postoperative complications, Mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Università Politecnica delle MarcheUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 Aug 2019 (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 aim of the study is to evaluate the complications rate of high risk patients undergoing non-cardiac surgery that receive two different protocols of hemodynamic optimization. A group of patients receive a protocol based on dynamic parameters of fluid responsiveness; the other group of patients receive a protocol based of the optimization of oxygen extraction.
The hypothesis is that a perioperative hemodynamic optimization protocol based on oxygen extraction is not inferior to a protocol based on dynamic parameters of fluid responsiveness considering the complication rate developed postoperatively.
Detailed description
Any surgical intervention is a trauma for the organism and a stress response is activated to cope the external insult. This stress response is responsible of an increase in oxygen consumption. If patient is not able to overcome the deficit in oxygen consumption (VO2) during the first hours postoperatively, he/she will go toward complications (in case of delay to meet metabolic demand) or death (in case of persistent VO2 deficit). Therefore, several protocols have been developed to optimise haemodynamic parameters with the aim to reduce tissue hypoperfusion coming from maldistribution or inadequate perfusion and meet the increased metabolic need as soon as possible.
Every patient that probably will not be able to face the surgical stress himself might benefit from modulation of haemodynamic parameters. Actually, goal directed therapy (GDT) is able to improve survival only in high-risk surgical patients. Instead, the reduction of complications rate has been shown also in intermediate-risk population.
Originally, hemodynamic optimisation protocols were developed to reach supranormal value for cardiac output (CO), oxygen delivery (DO2) and VO2. Based on the concept that oxygen extraction rate (O2ER) reflects the balance between DO2 and VO2, a GDT protocol based on O2ER estimation (O2ERe) calculated as (SaO2-ScvO2)/SaO2 has been proposed showing a significantly lower number of organ failure postoperatively compared with control group.
The major determinants of DO2 are cardiac output (CO), haemoglobin level (Hb) and arterial oxygen saturation (SaO2).
An inadequate CO may be optimised using fluids as first line therapy and then inotropes.
In mechanically ventilated patients, heart-lung interaction is useful to recognise in which portion of the Frank-Starling curve the heart of the patient is working and then if CO is able to rise after fluid administration aimed to increase preload. Several parameters based on mini-invasive monitor systems are available to assess fluid responsiveness such as pulse pressure variation (PPV) and stroke volume variation (SVV).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estimated Oxygen Extraction | Experimental | Diagnostic Test: Estimated oxygen extraction protocol |
| Dynamic Parameters | Active comparator | Diagnostic Test: Dynamic parameters of fluid responsiveness protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing general anesthesia and mechanical ventilation for elective major open abdominal surgery (gastrointestinal, urologic, gynecologic and vascular surgery)
- expected duration of surgical procedure higher than 120 minutes
- ASA II-III-IV
- planned postoperative ICU/HDU admission
Key exclusion criteria (6 listed)
- <18 years old
- pregnancy
- arrhythmia
- arterial curve alteration (resonance, damping) not solvable
- palliative surgical procedures
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 |
|---|---|---|
| Dynamic parameters of fluid responsiveness protocolDynamic parameter of fluid responsiveness (pulse pressure variation/stroke volume variation) are used to optimize hemodynamics intraoperatively and during the first 6 hours postoperatively when appropriate. A cutoff of 12% is used to predict an increase of stroke volume >10% after fluid administration. | Diagnostic test | Dynamic Parameters |
| Estimated oxygen extraction protocolOxygen extraction is estimated by the difference of arterial oxygen saturation and central venous oxygen saturation divided by arterial oxygen saturation. A cutoff of 27% is used as a marker of inadequate tissue perfusion requiring hemodynamic optimization. | Diagnostic test | Estimated Oxygen Extraction |
Primary outcome
Complications rate
Time frame: From date of randomization until the date of hospital discharge assessed up to 90 days
Evaluate the difference of postoperative complications rate between the two groups
5 secondary outcomes
Fluid administered
Time frame: Immediately after the surgery, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days
Fluid balance
Time frame: Immediately after the surgery, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days
Vasopressor/inopropic drugs
Time frame: Immediately after the, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days
Hospital length of stay
Time frame: From date of randomization until the date of hospital discharge or death from any cause assessed up to 90 days
Mortality at day 28
Time frame: Day 28 from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Derived from this study: PubMed 32305061Carsetti A, Amici M, Bernacconi T, Brancaleoni P, Cerutti E, Chiarello M, Cingolani D, Cola L, Corsi D, Forlini G, Giampieri M, Iuorio S, Principi T, Tappata G, Tempesta M, Adrario E, Donati A. Estimated oxygen extraction versus dynamic parameters of fluid-responsiveness for perioperative hemodynamic optimization of patients undergoing non-cardiac surgery: a non-inferiority randomized controlled trial. BMC Anesthesiol. 2020 Apr 18;20(1):87. doi: 10.1186/s12871-020-01011-z.
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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. This study is not recruiting at the moment.
Abele Donati, MD, PhD principal investigator
Università Politecnica delle Marche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic parameters of fluid responsiveness protocol and Estimated oxygen extraction protocol in people with Perioperative/Postoperative Complications and Morality, run by Università Politecnica delle Marche 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 6 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: status not confirmed, as of the sponsor's last update on 25 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abele Donati, MD, PhD (+390715963858, a.donati@univpm.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications rate (time frame: From date of randomization until the date of hospital discharge assessed up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04053595, which also lists 1 linked publication.
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 25 Mar 2020.