A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative… (NCT02145871) | Clinical Trial Compass
CompletedPhase 3
A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy
United States282 participantsStarted 2014-05-21
Plain-language summary
The purpose of this study is to help us learn what is the best amount of fluid to give to patients during bladder surgery in order to avoid delayed bowel function after surgery, which could prolong hospital stay.
Who can participate
Age range21 Years
SexALL
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Inclusion Criteria:
* Adults (21 years old or greater) who are able to provide informed consent
* Patients who undergo an open, elective radical cystectomy
Exclusion Criteria:
* Patients with active atrial fibrillation or flutter, since the algorithm is not accurate in case of cardiac arrhythmia
* Female patients who are pregnant (female patients of child-bearing potential must have a negative serum pregnancy test ≤ 14 days prior to surgery or 15 to 30 days prior to surgery with a negative urine pregnancy test the morning of surgery)
* Presence of ascites, because increased abdominal pressure interferes with EV1000 reading accuracy
* BMI \> 45 or \<17, because increased abdominal pressure interferes with EV1000 reading accuracy