Hemodynamic Optimization During Major Urological Surgery (INTAT)

Correlation Between IN-TArget Time for Mean Arterial Pressure and Stroke Volume During Major Urological Surgery and Tissue Perfusion: the INTAT Observational Study

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).

Study Overview

• Status: Completed
• Conditions: Hemodynamic Instability
• Intervention / Treatment: Device: Ev1000 Clinical Platform from Edwards Lifesciences

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00166
    • Andrea Russo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for major urological surgery who met the above mentioned inclusion criteria will be enrolled. All patients will belong the only study group in which a target-based hemodynamic protocol will be applied

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FloTrac patients; patients belong to this group will be managed with a stroke volume target hemodynamic protocol	Device: Ev1000 Clinical Platform from Edwards Lifesciences; The EV1000 Hemodynamic monitoring platform will be used to guide fluid administration following a volume-based parameter such the stroke volume.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	an average of 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postoperative overall complications	investigators will assess the impact of the intraoperative hemodynamic optimization on the rate of postoperative complications	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	an average of 2 weeks

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Andrea Russo, MD, Department of Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2018
• Primary Completion (Actual): July 21, 2020
• Study Completion (Actual): July 28, 2020

Study Registration Dates

• First Submitted: February 25, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: June 4, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: stroke volume; mean arterial pressure; goal directed therapy; major urological surgery
• Other Study ID Numbers: 1822

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No