The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy

Bladder Cancer Clinical Trial

Official title:

The Effect of Goal-directed Hemodynamic Therapy on Clinical Outcomes in Patients Undergoing Radical Cystectomy: : A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03505112
• Other study ID #: 1712-125-909
• Status: Completed
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: October 24, 2021

Study information

• Verified date: September 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: October 24, 2021
• Est. primary completion date: October 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Radical Cystectomy
• Urinary Bladder Neoplasms

Intervention

Other:
• Goal-directed therapy
The patients in GDT group will receive intravenous crystalloid fluid or vasopressor or inotropic agent according to the goal-directed therapy protocol utilizing FloTrac / EV1000 clinical platform (Edwards Lifesciences, Irvine, CA, USA). After induction of anesthesia, the baseline stroke volume index (SVI) is measured and then 200-250 ml of crystalloid is administered over 5-10 minutes. If SVI increase by =10%, 200-250 ml of crystalloid is given repeatedly until the increase in SVI <10%. If SVI does not increase by =10% and there is no decrease in mean arterial pressure (MAP), revaluate SVI every 10 minutes. Despite an increase in SVI of <10% after fluid challenge, if a decrease in MAP is accompanied by cardiac index (CI) = 2.5 L/min/m2, dobutamine is administered by continuous infusion. If there is a decrease in MAP but no decrease in CI, start low dose norepinephrine continuous infusion.

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	Seoul	Select

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. Erratum in: JAMA. 2014 Oct 8;312(14):1473. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite of postoperative complications	Total incidence of postoperative complications including gastrointestinal complications, complications of infections, wound complications, cardiac events, thromboembolic complications, genitourinary complications, neurological complications based on the Clavien-Dindo classification for radical cystectomy.	through the hospitalization period, an average of 2 weeks
Secondary	The incidence of postoperative gastrointestinal complications	Gastrointestinal complications include ileus, constipation, gastric ulcer, anastomic bowel leak according to the Clavien-Dindo classification for radical cystectomy.	through the hospitalization period, an average of 2 weeks
Secondary	The incidence of postoperative complications of infections	Complications of infections include urinary tract infection, sepsis, pneumonia, wound infection according to the Clavien-Dindo classification for radical cystectomy.	through the hospitalization period, an average of 2 weeks
Secondary	The incidence of postoperative wound complications	Wound Complications mean wound dehiscence diagnosed clinically and requiring resuturing, according to the Clavien-Dindo classification for radical cystectomy.	through the hospitalization period, an average of 2 weeks
Secondary	The incidence of postoperative cardiac events	Cardiac events include myocardial infarction, arrhythmia, congestive heart failure, pulmonary edema and transient brain natriuretic peptide increase (serum brain natriuretic peptide values 100-500 pg/ml) according to the Clavien-Dindo classification for radical cystectomy.	through the hospitalization period, an average of 2 weeks
Secondary	The incidence of postoperative thromboembolic complications	Thromboembolic complication means pulmonary embolism evidenced by spiral computerized tomography scanning according to the Clavien-Dindo classification for radical cystectomy.	through the hospitalization period, an average of 2 weeks
Secondary	The incidence of postoperative genitourinary complications	Genitourinary complications include renal dysfunction, renal failure, urinary leakage according to the Clavien-Dindo classification for radical cystectomy.	through the hospitalization period, an average of 2 weeks
Secondary	The incidence of postoperative neurological complications	Neurological complications mean presence of a de novo focal deficit, confusion/delirium according to the Clavien-Dindo classification for radical cystectomy.	through the hospitalization period, an average of 2 weeks