Hemodynamic Optimization During Major Urological Surgery

Fondazione Policlinico Universitario Agostino Gemelli IRCCS30 enrolled

Overview

In this prospective observational study investigators aim to seek for any possible correlation between the venous to arterial carbon dioxide difference (pCO2 gap) at the end of surgery and the percentage of time spent above a predefined threshold of stroke volume (SV) andn mean arterial pressure (MAP).

During major urological surgery (i.e. cistectomy) investigators will use a minimally invasive hemodynamic monitoring system (Flotrac - Vigileo, Edwards ) to guide fluid therapy and vasopressors administration. More specifically stroke volume target will be defined as the maximum SV after a series of fluid boluses, with a 10% tolerance. MAP was considered adequate if above 65 mmHg. After the induction of anesthesia, then each hour during surgery until the end of surgical procedure investigators will assess the time of adherence to the hemodynamic protocol (in terms of both SV and MAP) and the correspondent pCO2 gap. Investigators expect to find an inverse proportionality between the two parameters explored.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hemodynamic Instability

Interventions

Ev1000 Clinical Platform from Edwards LifesciencesDEVICE

The EV1000 Hemodynamic monitoring platform will be used to guide fluid administration following a volume-based parameter such the stroke volume.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients scheduled for major urological surgery * ASA 1-2-3 Exclusion Criteria: * pregnancy * obesity with a BMI \> 35 * controindications to central venous catheter positioning * end-stage renal disease

Locations (1)

Andrea Russo

Rome, Italy

Outcomes

Primary Outcomes

Correlation between the time-in target of MAP and the pCO2 gap at the end of surgery

The primary outcome will explore the hypothesis that patient with higher adherence of MAP levels above 65 mmHg will have a lower pCO2 gap at the end of surgery

Time frame: an average of 8 hours

Correlation between the time-in target of SV and the pCO2 gap at the end of surgery

The co-primary outcome will explore the hypothesis that patient with higher adherence of SV within the maximum value with a 10% tolerance, will have a lower pCO2 gap at the end of surgery

Time frame: an average of 8 hours

Secondary Outcomes

incidence of postoperative overall complications

investigators will assess the impact of the intraoperative hemodynamic optimization on the rate of postoperative complications

Time frame: up to 30 days

duration of hospitalization

investigators will prospectively evaluate the association between an intraoperative goal-directed fluid therapy with the long of stay

Time frame: an average of 2 weeks

Data from ClinicalTrials.gov

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