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

Overview

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.

Full Title of Study: “Impact of Goal Directed Fluid Therapy in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: April 2018

Interventions

  • Other: Control Group
    • Intraoperative fluids will be administer per the discretion of anesthesia provider and not per SVV data or study protocol.
  • Other: Treatment Group
    • FloTrac arterial line data will be used to administer fluid bolus, based on study algorithm.

Arms, Groups and Cohorts

  • Active Comparator: Control Group
    • 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.
  • Experimental: Treatment Group
    • The treatment group will receive a FloTrac arterial line that will allow the anesthesiologist to administer intraoperative fluids based on the study algorithm.

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative ileus
    • Time Frame: Up to 3 weeks postoperatively
    • Time postoperatively to first bowel movement

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Loma Linda University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ronak Raval, MD – Loma Linda University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.