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BRIEF TITLE: Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy

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


  • Org Study ID: 14-069
  • Secondary ID:
  • NCT ID: NCT02145871
  • NCT Alias:
  • Sponsor: Memorial Sloan Kettering Cancer Center - Other
  • Source: Memorial Sloan Kettering Cancer Center

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.

Overal Status Start Date Phase Study Type
Recruiting May 2014 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: incidence of postoperative ileus (POI)

Primary Outcome 1 - Time Frame: 3 years

Condition:

  • Bladder Cancer

Eligibility

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
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Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Vittoria Arslan-Carlon, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Vittoria Arslan-Carlon, MD

Phone: 212-639-2680

Email:

Link: Memorial Sloan Kettering Cancer Center

Locations

Facility Status Contact
Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Recruiting Vittoria Arslan-Carlon, MD
212-639-2680
Memoral Sloan Kettering Monmouth
Middletown, New Jersey 07748
United States
Recruiting Vittoria Arslan-Carlon, MD
212-639-2680
Memorial Sloan Kettering Cancer Center @ Commack
Commack, New York 11725
United States
Recruiting Vittoria Arslan-Carlon, MD
212-639-2680
Memoral Sloan Kettering Westchester
Harrison, New York 10604
United States
Recruiting Vittoria Arslan-Carlon, MD
212-639-2680
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United States
Recruiting Vittoria Arslan-Carlon, MD
212-639-2680