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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.
Verified August 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02145871
First Posted: May 23, 2014
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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 ]
    given intraoperatively and during the first 72 hrs postoperatively


Estimated Enrollment: 282
Actual Study Start Date: May 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145871


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

Locations
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Vittoria Arslan-Carlon, MD    212-639-2680      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Vittoria Arslan-Carlon, MD    212-639-2680      
United States, New York
Memorial Sloan Kettering Cancer Center @ Commack Recruiting
Commack, New York, United States, 11725
Contact: Vittoria Arslan-Carlon, MD    212-639-2680      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Vittoria Arslan-Carlon, MD    212-639-2680      
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:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02145871     History of Changes
Other Study ID Numbers: 14-069
First Submitted: May 21, 2014
First Posted: May 23, 2014
Last Update Posted: September 6, 2017
Last Verified: August 2017

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