A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy

Completed · Phase 3

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID: NCT02145871
Run by: Memorial Sloan Kettering Cancer Center
People needed: 282
Starts: 2014-05-21
Expected to finish: 2024-03-14
Last updated by the study team: 2024-03-20

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Adults (21 years old or greater) who are able to provide informed consent
Patients who undergo an open, elective radical cystectomy

You may not qualify if…

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

Where it is running

Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Commack — Commack, New York, United States
Memorial Sloan Kettering Westchester — Harrison, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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