Liver Cancer
Conditions
Keywords
Perioperative Fluid Management, liver resection, 12-056
Brief summary
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.
Interventions
PROCEDUREStandard fluid management
The patient will receive standard fluid management
DEVICEGoal directed fluid therapy with the Edwards EV1000 system
This arm will have fluid therapy guided by the Edwards EV1000 system.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complications | 30 days post procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low Cardiac Output Time | Up to the first 24 postoperative hours | Assess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively |
| Total Volume of Fluid Used Perioperatively | Up to the first 72 hours postoperatively | Assess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively |
| Total Volume of Fluid Used Postoperatively | Postoperatively for the total admission time, up to 8 days | Postoperative fluid volume |
| Postoperative Length of Stay | Postoperatively for the total admission time, up to 8 days | Assess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Goal-directed Therapy | 69 |
| Standard Perioperative Resuscitation | 66 |
| Total | 135 |
Baseline characteristics
| Characteristic | Goal-directed Therapy | Standard Perioperative Resuscitation | Total |
|---|---|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 13 | 58 years STANDARD_DEVIATION 14 | 57 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 69 Participants | 66 Participants | 135 Participants |
| Sex: Female, Male Female | 36 Participants | 39 Participants | 75 Participants |
| Sex: Female, Male Male | 33 Participants | 27 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 3 / 69 |
| other Total, other adverse events | 66 / 66 | 69 / 69 |
| serious Total, serious adverse events | 23 / 66 | 46 / 69 |
Outcome results
Primary
Postoperative Complications
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.
Time frame: 30 days post procedure
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Fluid Management | Postoperative Complications | 30-day survival | 42 Participants |
| Standard Fluid Management | Postoperative Complications | 30-day overall morbidity | 24 Participants |
| Goal Directed Fluid Therapy | Postoperative Complications | 30-day survival | 45 Participants |
| Goal Directed Fluid Therapy | Postoperative Complications | 30-day overall morbidity | 24 Participants |
Secondary
Low Cardiac Output Time
Assess the impact of GDT compared to standard fluid therapy on the total time patients experience low cardiac output perioperatively
Time frame: Up to the first 24 postoperative hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Fluid Management | Low Cardiac Output Time | 21 minutes | Standard Deviation 113 |
| Goal Directed Fluid Therapy | Low Cardiac Output Time | 12 minutes | Standard Deviation 48 |
Secondary
Postoperative Length of Stay
Assess the impact of GDT compared to standard fluid therapy on net fluid balance for the total admission time
Time frame: Postoperatively for the total admission time, up to 8 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Fluid Management | Postoperative Length of Stay | 7 days |
| Goal Directed Fluid Therapy | Postoperative Length of Stay | 6 days |
Secondary
Total Volume of Fluid Used Perioperatively
Assess the impact of GDT compared to standard fluid therapy on the total volume of fluid given intraoperatively
Time frame: Up to the first 72 hours postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Fluid Management | Total Volume of Fluid Used Perioperatively | 2.0 liter | Standard Deviation 1.1 |
| Goal Directed Fluid Therapy | Total Volume of Fluid Used Perioperatively | 2.9 liter | Standard Deviation 1 |
Secondary
Total Volume of Fluid Used Postoperatively
Postoperative fluid volume
Time frame: Postoperatively for the total admission time, up to 8 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Fluid Management | Total Volume of Fluid Used Postoperatively | 0.9 liter | Standard Deviation 0.6 |
| Goal Directed Fluid Therapy | Total Volume of Fluid Used Postoperatively | 1.0 liter | Standard Deviation 0.5 |