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

Memorial Sloan Kettering Cancer Center5 sites in 1 country282 target enrollmentMay 21, 2014

ConditionsBladder Cancer

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Bladder Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 282
Locations: 5
Primary Endpoint: incidence of postoperative ileus (POI)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 21, 2014

End Date

March 14, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

incidence of postoperative ileus (POI)

Time Frame: 3 years

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.