Clinical trial · Interventional
The Effect of Goal-directed Hemodynamic Therapy in Radical Cystectomy
The Effect of Goal-directed Hemodynamic Therapy on Clinical Outcomes in Patients Undergoing Radical Cystectomy: : A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Radical Cystectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Goal-directed therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Goal-directed therapy group
- description
- The patients in goal-directed therapy (GDT) group will be managed according to the goal-directed therapy protocol during the surgery.
- interventionNames
- Other: Goal-directed therapy
- type
- NO_INTERVENTION
- label
- Control group
- description
- The patients in control group will be managed according to standard perioperative care.
Primary outcomes (1)
- measure
- A composite of postoperative complications
- timeFrame
- through the hospitalization period, an average of 2 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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)
References
Publications (3)
- BACKGROUNDWuethrich 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. PMID 23887199
- BACKGROUNDPearse 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. PMID 24842135
- DERIVEDYoon HK, Hur M, Kim DH, Ku JH, Kim JT. The effect of goal-directed hemodynamic therapy on clinical outcomes in patients undergoing radical cystectomy: a randomized controlled trial. BMC Anesthesiol. 2023 Oct 9;23(1):339. doi: 10.1186/s12871-023-02285-9. PMID 37814224