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Estimated Oxygen Extraction Versus Dynamic Parameters for Perioperative Hemodynamic Optimization

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ClinicalTrials.gov Identifier: NCT04053595
Recruitment Status : Not yet recruiting
First Posted : August 12, 2019
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
Abele Donati, MD, Università Politecnica delle Marche

Brief 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 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.


Condition or disease Intervention/treatment Phase
Perioperative/Postoperative Complications Morality Diagnostic Test: Dynamic parameters of fluid responsiveness protocol Diagnostic Test: Estimated oxygen extraction protocol Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Estimated Oxygen Extraction Versus Dynamic Parameters for Perioperative Hemodynamic Optimization of Patients Undergoing Non-cardiac Surgery: a Non-inferiority Randomized Controlled Trial
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Estimated Oxygen Extraction Diagnostic Test: Estimated oxygen extraction protocol
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.

Active Comparator: Dynamic Parameters Diagnostic Test: Dynamic parameters of fluid responsiveness protocol
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Fluid administered [ Time Frame: Immediately after the surgery, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days ]
    Evaluate the difference of total amount of fluids administered during the perioperative period between the two groups

  2. Fluid balance [ Time Frame: Immediately after the surgery, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days ]
    Evaluate the difference of fluid balance (difference between fluid administered and fluid loss) during postoperative period between the two groups

  3. Vasopressor/inopropic drugs [ Time Frame: Immediately after the, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days ]
    Evaluate the difference in needs of vasopressor/inotropic drugs (reporting mean dosage used) between the two groups

  4. 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 ]
    Evaluate the difference of total number of days of hospital stay between the two groups

  5. Mortality at day 28 [ Time Frame: Day 28 from randomization ]
    Evaluate the difference of mortality rate at day 28 between the two groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • <18 years old
  • pregnancy
  • arrhythmia
  • arterial curve alteration (resonance, damping) not solvable
  • palliative surgical procedures
  • denial of consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053595


Contacts
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Contact: Abele Donati, MD, PhD +390715963858 a.donati@univpm.it

Locations
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Italy
AOU Ospedali Riuniti Ancona
Ancona, Italy, 60126
Sponsors and Collaborators
Università Politecnica delle Marche
Investigators
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Principal Investigator: Abele Donati, MD, PhD Università Politecnica delle Marche

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Responsible Party: Abele Donati, MD, Professor, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT04053595     History of Changes
Other Study ID Numbers: CLRZ01-19
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abele Donati, MD, Università Politecnica delle Marche:
Peri-operative goal-directed therapy
Hemodynamic optimization
Postoperative complications
Mortality
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes