NCT04053595

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

June 11, 2019

Last Update Submit

March 23, 2020

Conditions

Perioperative/Postoperative ComplicationsMorality

Keywords

Peri-operative goal-directed therapyHemodynamic optimizationPostoperative complicationsMortality

Outcome Measures

Primary Outcomes (1)

  • Complications rate

    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 Outcomes (5)

  • Fluid administered

    Immediately after the surgery, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days

  • Fluid balance

    Immediately after the surgery, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days

  • Vasopressor/inopropic drugs

    Immediately after the, 6 hours postoperatively and at the date of ICU/HDU discharge assessed up to 90 days

  • Hospital length of stay

    From date of randomization until the date of hospital discharge or death from any cause assessed up to 90 days

  • Mortality at day 28

    Day 28 from randomization

Study Arms (2)

Estimated Oxygen Extraction

EXPERIMENTAL
Diagnostic Test: Estimated oxygen extraction protocol

Dynamic Parameters

ACTIVE COMPARATOR
Diagnostic Test: Dynamic parameters of fluid responsiveness protocol

Interventions

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.

Dynamic Parameters
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.

Estimated Oxygen Extraction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Ospedali Riuniti Ancona

Ancona, 60126, Italy

Location

Related Publications (1)

  • 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.

    PMID: 32305061DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Abele Donati, MD, PhD

    Università Politecnica delle Marche

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abele Donati, MD, PhD

CONTACT

+390715963858a.donati@univpm.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 11, 2019

First Posted

August 12, 2019

Study Start

June 1, 2020

Primary Completion

June 1, 2021

Study Completion

December 1, 2021

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

IT(1)