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

NCT02145871 | Completed Phase 3

• 1 other identifier: 14-069
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 5

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.

Conditions

Bladder Cancer

Keywords

Radical Cystectomy; Perioperative Fluid Management; EV1000; 14-069

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• complications

  1 year post operatively

• compare total volume of fluid

  the first 72 hours

Study Arms (2)

Standard fluid management

ACTIVE COMPARATOR

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

Goal directed fluid therapy (GDT)

EXPERIMENTAL

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

Interventions

standard fluid management OTHER

Standard fluid management

fluid management guided by the EV1000 OTHER

Goal directed fluid therapy (GDT)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (5)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Cancer Center @ Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Vittoria Arslan-Carlon, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: May 21, 2014
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

US (5)