A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy
Conditions
Bladder Cancer
Conditions: Keywords
Radical Cystectomy, Perioperative Fluid Management, EV1000, 14-069
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: standard fluid management Type: Other
Name: fluid management guided by the EV1000 Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Both
Criteria: 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
Locations
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Vittoria Arslan-Carlon, MD - 212-639-2680
Memorial Sloan Kettering West Harrison
West Harrison, New York, United States
Status: Recruiting
Contact: Vittoria Arslan-Carlon, MD - 212-639-2680
Start Date
May 2014
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page