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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02145871
First received: May 21, 2014
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Bladder Cancer
Other: standard fluid management
Other: fluid management guided by the EV1000
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 282
Study Start Date: May 2014
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02145871

Contacts
Contact: Vittoria Arslan-Carlon, MD 212-639-2680
Contact: Mary Fischer, MD 212-639-6745

Locations
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         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Vittoria Arslan-Carlon, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02145871     History of Changes
Other Study ID Numbers: 14-069
Study First Received: May 21, 2014
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Radical Cystectomy
Perioperative Fluid Management
EV1000
14-069

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014