RecruitingNot ApplicableNCT03113435

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

Patient Management During Major Abdominal Surgery: the Impact of a Hemodynamic Approach Oriented to Oxygen Consumption Optimization Compared to Standard Approach Targeting Preload-dependency and a Clinically-guided Strategy


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

76 participants

Start Date

Jun 1, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • patients aged > 18 years
  • acquisition of written informed consent
  • Major abdominal surgery (major gastrointestinal surgery: DCP, gastrectomy, Miles, emicolectomy; gynecologic surgery: oncologic surgery) Surgery times ≥ 3 hours

Exclusion Criteria8

  • Absolute contraindication to CVC placement
  • pregnant women
  • hepatic surgery
  • laparoscopic surgery
  • Major vascular surgery
  • Dialysis treatment and kidney transplant surgery
  • Severe heart failure (EF ≤ 35%)
  • Emergency surgery

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Interventions

OTHEROxygen consumption optimization

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


Locations(1)

Fondazione Policlinico A. Gemelli IRCCS

Roma, Italy

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NCT03113435


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