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Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach

NCT03113435 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-03-11

No results posted yet for this study

Summary

This study compares the actual standard of care with a new protocol to guide hemodynamic optimization during major abdominal surgery, which is more tailored on patient real needs. During general anesthesia metabolic needs of the body are markedly reduced and increase in CO may not be necessary. In addition, excessive fluid administration has been related to worse post-operative outcomes. We divide patients into three groups: the standard treatment group, the NICE protocol group and the intervention group. In this group we use the v-aCO2/CaO2-CvO2 as marker of tissue ability to increase their oxygen consumption in response to increased O2 delivery, and based on this index the administration of fluid. The principal aim is to optimize functional hemodynamics in order to reduce the fluid balance at the end of the surgery.

Conditions

  • Hemodynamic Instability

Interventions

OTHER

Oxygen consumption optimization

hemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio

Sponsors & Collaborators

  • Flavia Torrini

    collaborator UNKNOWN

  • Alessandra Bisanti

    collaborator UNKNOWN

  • Eleonora Filipponi

    collaborator UNKNOWN

  • Domenica Luca Grieco

    collaborator UNKNOWN

  • Massimo Antonelli

    collaborator UNKNOWN

  • Liliana Sollazzi

    collaborator UNKNOWN

  • Valter Perilli

    collaborator UNKNOWN

  • Andrea Russo

    collaborator UNKNOWN

  • Pierpaolo Ciocchetti

    collaborator UNKNOWN

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Antonio M Dell'Anna, MD · Fondazione Policlinico Universitario A. Gemelli

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2026-07-31
Completion
2026-12-31

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 NCT03113435 on ClinicalTrials.gov