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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Liver Cancer

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Trial Information

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


Inclusion Criteria:



- Adults (18 years old or greater) who are able to provide informed consent.

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

Exclusion Criteria:

- Active coronary disease.

- Patients with a history of coronary disease will be eligible if they have had a
cardiac stress study showing no reversible ischemia and normal LV function within 3
months of operation.

- Active symptomatic cerebrovascular disease.

- Active congestive heart failure and ejection fraction <35%.

- Active severe restrictive or obstructive pulmonary disease and resting SpO2 <90%.

- Active renal dysfunction (Cr >1.8)

- Abnormal coagulation parameters (INR > 1.8 not on Coumadin, or platelet count <
100,000 per mcL)

- Presence of active infection including HIV

- Patients with active atrial fibrillation or flutter.

- Preoperative hypoalbuminemia (Albumin < 2g/dl).

- 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.

- BMI > 45 or <17

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

postoperative complications

Outcome Description:

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.

Outcome Time Frame:

2 year

Safety Issue:

Yes

Principal Investigator

Mary Fischer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-056

NCT ID:

NCT01596283

Start Date:

April 2012

Completion Date:

April 2014

Related Keywords:

  • Liver Cancer
  • Perioperative Fluid Management
  • liver resection
  • 12-056
  • Liver Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021