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Completed

NCT Number: NCT03474224

Hemodynamic Optimization During Major Urological Surgery

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).

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Key information

Conditions

Hemodynamic Instability

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Andrea Russo

Rome, 00166, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ev1000 Clinical Platform from Edwards Lifesciences

Device

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

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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 outcomes

  1. incidence of postoperative overall complications

    Time frame: up to 30 days

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

  2. duration of hospitalization

    Time frame: an average of 2 weeks

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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: INTAT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2018
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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