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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03213574

Enrollment

Registered

2017-07-11

Start date

2017-12-31

Completion date

2018-04-30

Last updated

2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypervolemia, Hypovolemia, Vascular Hypotension

Keywords

Goal directed fluid therapy

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.

Interventions

OTHERControl Group

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

OTHERTreatment Group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative ileus	Up to 3 weeks postoperatively	Time postoperatively to first bowel movement

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026