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Estimated Oxygen Extraction Versus Dynamic Parameters for Perioperative Hemodynamic Optimization

NCT04053595 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-03-25

No results posted yet for this study

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.

Conditions

  • Perioperative/Postoperative Complications
  • Morality

Interventions

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.

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.

Sponsors & Collaborators

  • Università Politecnica delle Marche

    lead OTHER

Principal Investigators

  • Abele Donati, MD, PhD · Università Politecnica delle Marche

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-06-30
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04053595 on ClinicalTrials.gov