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The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy

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Seoul National University

Status

Completed

Conditions

Bladder Cancer
Radical Cystectomy

Treatments

Other: Goal-directed therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03505112
1712-125-909

Details and patient eligibility

About

Goal-directed therapy (GDT) has been applied to various clinical settings and has been widely researched recently as a method for perioperative management of patients. Radical cystectomy is a complex surgical procedure in which the bladder is removed, followed by urinary diversion. It is an extensive and time-consuming intervention and has high probability of fluid imbalance and bleeding during surgery. We hypothesized that the application of GDT in these patients would improve clinical postoperative outcomes. Therefore, we will attempt to evaluate improvement of postoperative outcomes after applying GDT protocol based on changes in stroke volume index, cardiac index and mean arterial pressure in radical cystectomy.

Enrollment

82 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing open radical cystectomy
  • Patients with American Society of Anesthesiologists physical status I-III

Exclusion criteria

  • Significant hepatic dysfunction, significant renal dysfunction (estimated glomerular filtration rate <60 ml/min)
  • Congestive heart failure (New York Heart Association scores ≥3), Left Ventricular Ejection Fraction < 35%
  • Arrhythmia
  • Coagulopathy (PT INR >1.5)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

82 participants in 2 patient groups

Goal-directed therapy group
Experimental group
Description:
The patients in goal-directed therapy (GDT) group will be managed according to the goal-directed therapy protocol during the surgery.
Treatment:
Other: Goal-directed therapy
Control group
No Intervention group
Description:
The patients in control group will be managed according to standard perioperative care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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