Hemodynamic Optimization During Major Urological Surgery

Hemodynamic Instability Clinical Trial

— INTAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474224
• Other study ID #: 1822
• Status: Completed
• Start date: October 5, 2018
• Est. completion date: July 28, 2020

Study information

• Verified date: June 2022
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 28, 2020
• Est. primary completion date: July 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

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.

Locations

Country	Name	City	State
Italy	Andrea Russo	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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