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

Hypovolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03213574
• Other study ID #: 5170073
• Status: Withdrawn
• Phase: N/A
• First received: February 6, 2017
• Last updated: April 4, 2018
• Start date: December 2017
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypervolemia
• Hypotension
• Hypovolemia
• Vascular Hypotension

Intervention

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

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

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