Hemodynamic Optimization During Major Urological Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03474224

Acronym

INTAT

Enrollment

Registered

2018-03-22

Start date

2018-10-05

Completion date

2020-07-28

Last updated

2022-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability

Keywords

stroke volume, goal directed therapy, major urological surgery, mean arterial pressure

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.

Interventions

DEVICEEv1000 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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Secondary

Measure	Time frame	Description
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
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026