Estimated Oxygen Extraction Versus Dynamic Parameters for Perioperative Hemodynamic Optimization

March 23, 2020 updated by: Abele Donati, MD, Università Politecnica delle Marche

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ancona, Italy, 60126
        • AOU Ospedali Riuniti Ancona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of randomization until the date of hospital discharge assessed up to 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Evaluate the difference of fluid balance (difference between fluid administered and fluid loss) during postoperative period between the two groups
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
Evaluate the difference in needs of vasopressor/inotropic drugs (reporting mean dosage used) between the two groups
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
Evaluate the difference of total number of days of hospital stay between the two groups
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
Evaluate the difference of mortality rate at day 28 between the two groups
Day 28 from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Politecnica delle Marche

Investigators

  • Principal Investigator: Abele Donati, MD, PhD, Università Politecnica delle Marche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

June 11, 2019

First Submitted That Met QC Criteria

August 8, 2019

First Posted (Actual)

August 12, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLRZ01-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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