Impact of GDT in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients

Study Overview
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Brief Summary
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Robot assisted urological procedures are often long surgical cases that can potentially result in complicated postoperative hospital course. The amount of intravenous (IV) fluids administered to patients during these operations fluctuates based on the length of the case, surgical blood loss, hemodynamic monitors, and the discretion of the anesthesiologist. The goal of intraoperative fluid therapy is to maintain optimal tissue perfusion without causing fluid overload. We plan to use a goal directed fluid therapy protocol to optimize fluid status and analyze post-operative outcomes.

Official Title
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Impact of Goal Directed Fluid Therapy in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients

Conditions
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Vascular Hypotension, Hypovolemia, Hypervolemia

Intervention / Treatment
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* Other: Control Group
* Other: Treatment Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing robot-assisted laparoscopic urological procedures in which the patient would have an arterial catheter placed as part of their routine inoperative anesthetic management Exclusion Criteria: Age less than 18; current pregnancy; history of congestive heart failure, arrhythmias, coagulopathy, cerebral vascular disease , COPD, significant liver or renal impairment, required FloTrac per treating anesthesiologist; patient refusal to consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>The control group will be administered intraoperative fluids throughout his or her surgery per the discretion of the anesthesiologist as is typical for this type of case. They will use an arterial line but without a FloTrac and therefore will have no data regarding the SVV. | Other: Control Group<br>* Intraoperative fluids will be administer per the discretion of anesthesia provider and not per SVV data or study protocol.<br>|
| Experimental: Treatment Group<br>The treatment group will receive a FloTrac arterial line that will allow the anesthesiologist to administer intraoperative fluids based on the study algorithm. | Other: Treatment Group<br>* FloTrac arterial line data will be used to administer fluid bolus, based on study algorithm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative ileus | Time postoperatively to first bowel movement | Up to 3 weeks postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury | Will be measured using the KDIGO criteria (UOP and Cr) | Up to 3 weeks postoperatively | 
| Respiratory compromise | Patients that require oxygen or invasive/non-invasive mechanical ventilation postoperatively | Up to 3 weeks postoperatively | 
| Need for diuresis | Use of a diuretic medication (ex. lasix, metolazone) | Up to 3 weeks postoperatively | 
| Hospital length of stay | Duration of stay in the hospital | Up to 4 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Goal directed fluid therapy