Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

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

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.

standard fluid management

fluid management guided by the EV1000

Vittoria Arslan-Carlon, MD

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.

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

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.

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.

given intraoperatively and during the first 72 hrs postoperatively

Memorial Sloan Kettering Cancer Center

Digestive System Diseases

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Liver Extracts

Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.

The patient will receive standard fluid management

Standard fluid management

This arm will have fluid therapy guided by the Edwards EV1000 system.

Goal directed fluid therapy with the Edwards EV1000 system

Mary Fischer, MD

The purpose of this study is to help us learn what is the best amount of fluid to administer to patients during liver surgery. Patients will receive either an amount for this surgery based on weight, blood pressure, heart rate and urine output or an amount guided by a computerized system (FloTrac) that helps doctors know how much fluid each patient needs. The FloTrac calculates the amount of fluid patients needs on a minute-to-minute basis, based on real time information like blood pressure, pulse and the ability of the heart and blood vessels to maintain normal vital signs.

Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection

A Prospective Randomized Controlled Clinical Trial of Standard Compared to Goal-directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection

The incidence of overall 30-day postoperative complications will be recorded. These are defined in the MSKCC Adverse Events Program and organized by categories reflecting organ systems and further subdivided into specific complications within those and graded.

Assess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively

Assess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively

Assess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time

Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.

Standard fluid management: The patient will receive standard fluid management

Standard Fluid Management

Prospective single-blinded randomized trial. Eligible patients will be consented for the trial prior to surgery. However randomization will not occur until the operating room. After the liver has been resected, intraoperative randomization will be done by envelopes.

Goal directed fluid therapy with the Edwards EV1000 system: This arm will have fluid therapy guided by the Edwards EV1000 system.

Goal Directed Fluid Therapy

Goal-directed Therapy

Standard Perioperative Resuscitation

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Mary Fischer MD

Postoperative Complications

Low Cardiac Output Time

Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures. Goal-directed therapy (GDT) embodies a number of physiologic strategies to achieve an ideal fluid balance and avoid the consequences of over- or under-resuscitation.

Goal-directed Therapy (GDT) After Liver Resection

Patients who undergo an open, elective liver resection, Including those initially approached laparoscopically but converted to an open resection and those undergoing additional procedures.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Prospective Randomized Controlled Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Radical Cystectomy	NCT02145871	Bladder Cancer	standard fluid ... fluid managemen...	21 Years -	Memorial Sloan Kettering Cancer Center
Clinical Trial of Standard Versus Goal-Directed Perioperative Fluid Management (GDT) for Patients Undergoing Liver Resection	NCT01596283	Liver Cancer	Standard fluid ... Goal directed f...	18 Years -	Memorial Sloan Kettering Cancer Center

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