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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2022

Interventions

  • Other: standard fluid management
  • Other: fluid management guided by the EV1000

Arms, Groups and Cohorts

  • 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
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • complications
    • Time Frame: 1 year post operatively
    • 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.
  • compare total volume of fluid
    • Time Frame: the first 72 hours
    • given intraoperatively and during the first 72 hrs postoperatively

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vittoria Arslan-Carlon, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.