Hemodynamic Optimization During Major Urological Surgery

Completed

• Conditions: Hemodynamic Instability
• Interventions: Device: Ev1000 Clinical Platform from Edwards Lifesciences

• Registration Number: NCT03474224
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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).

Detailed Description

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 Timeline

• Study First Submitted: 2018-02-25
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-22
• Study Start: 2018-10-05
• Primary Completion: 2020-07-21
• Study Completion: 2020-07-28
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-04
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
FloTrac patients	Ev1000 Clinical Platform from Edwards Lifesciences	patients belong to this group will be managed with a stroke volume target hemodynamic protocol

Primary Outcome Measures

Name	Time	Method
Correlation between the time-in target of SV and the pCO2 gap at the end of surgery	an average of 8 hours	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
Correlation between the time-in target of MAP and the pCO2 gap at the end of surgery	an average of 8 hours	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

Secondary Outcome Measures

Name	Time	Method
duration of hospitalization	an average of 2 weeks	investigators will prospectively evaluate the association between an intraoperative goal-directed fluid therapy with the long of stay
incidence of postoperative overall complications	up to 30 days	investigators will assess the impact of the intraoperative hemodynamic optimization on the rate of postoperative complications

Trial Locations

Locations (1)

Andrea Russo; 🇮🇹 Rome, Italy