Clinical trial NCT03505112: The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy
Official title: The Effect of Goal-directed Hemodynamic Therapy on Clinical Outcomes in Patients Undergoing Radical Cystectomy: : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Radical Cystectomy
Keywords: Goal-directed therapy
stroke volume index
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-center, double-blind, parallel-group, randomized, controlled trial
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: A composite of postoperative complications
timeFrame: through the hospitalization period, an average of 2 weeks
Secondary outcomes:
measure: The incidence of postoperative gastrointestinal complications
timeFrame: through the hospitalization period, an average of 2 weeks
measure: The incidence of postoperative complications of infections
timeFrame: through the hospitalization period, an average of 2 weeks
measure: The incidence of postoperative wound complications
timeFrame: through the hospitalization period, an average of 2 weeks
measure: The incidence of postoperative cardiac events
timeFrame: through the hospitalization period, an average of 2 weeks
measure: The incidence of postoperative thromboembolic complications
timeFrame: through the hospitalization period, an average of 2 weeks
measure: The incidence of postoperative genitourinary complications
timeFrame: through the hospitalization period, an average of 2 weeks
measure: The incidence of postoperative neurological complications
timeFrame: through the hospitalization period, an average of 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
state: Select
Study officials:
References:
citation: Wuethrich PY, Burkhard FC, Thalmann GN, Stueber F, Studer UE. Restrictive deferred hydration combined with preemptive norepinephrine infusion during radical cystectomy reduces postoperative complications and hospitalization time: a randomized clinical trial. Anesthesiology. 2014 Feb;120(2):365-77. doi: 10.1097/ALN.0b013e3182a44440.
citation: Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305.