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
Verified date | September 2022 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Jin-Tae Kim | Seoul | Select |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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
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 |
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