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

NCT03213574 | Withdrawn

• 1 other identifier: 5170073
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Hypotension; Hypovolemia; Hypervolemia

Keywords

Goal directed fluid therapy

Outcome Measures

Primary Outcomes (1)

• Postoperative ileus

  Time postoperatively to first bowel movement

  Up to 3 weeks postoperatively

Secondary Outcomes (4)

• Acute kidney injury

  Up to 3 weeks postoperatively

• Respiratory compromise

  Up to 3 weeks postoperatively

• Need for diuresis

  Up to 3 weeks postoperatively

• Hospital length of stay

  Up to 4 weeks postoperatively

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Treatment Group

EXPERIMENTAL

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

Interventions

Control Group OTHER

Intraoperative fluids will be administer per the discretion of anesthesia provider and not per SVV data or study protocol.

Control Group

Treatment Group OTHER

FloTrac arterial line data will be used to administer fluid bolus, based on study algorithm.

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Hypotension; Hypovolemia; Edema

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: July 11, 2017
• Study Start: December 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)