A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy
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.
Other: standard fluid management
Other: fluid management guided by the EV1000
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy|
- incidence of postoperative ileus (POI) [ Time Frame: 3 years ] [ Designated as safety issue: No ]POI will be defined as intolerance of oral intake by postoperative day 5, or the cessation of diet and/or placement of an NGT for clinical signs or symptoms associated with POI, including one or more of the following: nausea, emesis, abdominal bloating or distension, or excessive burping. Rate of ileus will be compared between the treatment groups using the chi-square test. A 95% confidence interval for the difference in ileus rate will also be reported.
- complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Overall rate of grade 2-5 30-day complications, and rate of grade 2-5 gastrointestinal, pulmonary, renal, hematologic and cardiac complications will also be compared using the chi-square test. Based rate of grade 2-5 gastrointestinal, pulmonary, renal, hematologic and cardiac complications will also be compared using the chi-square test.
- compare total volume of fluid [ Time Frame: the first 72 hours ] [ Designated as safety issue: No ]given intraoperatively and during the first 72 hrs postoperatively
|Study Start Date:||May 2014|
|Estimated Primary Completion Date:||May 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Standard fluid management
The non-intervention group will receive maintenance crystalloid fluid at 10cc/kg/h. Blood loss will be replaced 1:1 with albumin. Transfusion will follow transfusion criteria. Fluid management will not be dependent on the EV1000
|Other: standard fluid management|
Experimental: Goal directed fluid therapy (GDT)
In the GDT arm, patient's SV will be optimized before induction with crystalloid boluses prior to induction of general anesthesia. The GDT arm will have fluid therapy guided by the Edwards EV1000-clinical platform and maintenance crystalloid fluid will be 3cc/kg/h. During the surgical procedure when SVV rises above 12 an albumin bolus will be administered at 250 ml increments until the SVV falls below 8. Transfusion will follow transfusion criteria.
|Other: fluid management guided by the EV1000|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02145871
|Contact: Vittoria Arslan-Carlon, MD||212-639-2680|
|Contact: Mary Fischer, MD||212-639-6745|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10021|
|Contact: Vittoria Arslan-Carlon, MD 212-639-2680|
|Contact: Mary Fischer, MD 212-639-6745|
|Principal Investigator: Vittoria Arslan-Carlon, MD|
|Principal Investigator:||Vittoria Arslan-Carlon, MD||Memorial Sloan-Kettering Cancer Center|