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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145871
• Other study ID #: 14-069
• Status: Completed
• Phase: Phase 3
• Start date: May 21, 2014
• Est. completion date: March 14, 2024

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: March 14, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• standard fluid management

• fluid management guided by the EV1000

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	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 Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postoperative ileus (POI)	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.	3 years
Secondary	complications	Overall rate of grade 2-5 1-year 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.	1 year post operatively
Secondary	compare total volume of fluid	given intraoperatively and during the first 72 hrs postoperatively	the first 72 hours

External Links

•   Memorial Sloan Kettering Cancer Center