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
1 other identifier
observational
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2018
CompletedFirst Posted
Study publicly available on registry
March 22, 2018
CompletedStudy Start
First participant enrolled
October 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2020
CompletedJune 7, 2022
June 1, 2022
1.8 years
February 25, 2018
June 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
incidence of postoperative overall complications
up to 30 days
duration of hospitalization
an average of 2 weeks
Study Arms (1)
FloTrac patients
patients belong to this group will be managed with a stroke volume target hemodynamic protocol
Interventions
The EV1000 Hemodynamic monitoring platform will be used to guide fluid administration following a volume-based parameter such the stroke volume.
Eligibility Criteria
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
You may qualify if:
- patients scheduled for major urological surgery
- ASA 1-2-3
You may not qualify if:
- pregnancy
- obesity with a BMI \> 35
- controindications to central venous catheter positioning
- end-stage renal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Andrea Russo
Rome, 00166, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Russo, MD
Department of Anesthesiology
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
February 25, 2018
First Posted
March 22, 2018
Study Start
October 5, 2018
Primary Completion
July 21, 2020
Study Completion
July 28, 2020
Last Updated
June 7, 2022
Record last verified: 2022-06