Effect of SVV Guided Fluid Therapy on Blood Loss and Postoperative Outcomes

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effect of stroke volume variation (SVV) guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy.

Detailed Description
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The purpose of this study is to investigate the effect of stroke volume variation(SVV) guided fluid therapy on the blood loss and postoperative outcomes in radical cystectomy. Patients were randomized to fluid management to maintain <10% SVV (group A), or to undergo fluid management during radical cystectomy to maintain SVV 10-20% (group B). Intraoperative blood loss and hemodynamic parameters, perioperative laboratory data, and postoperative complications were compared between two groups.

Official Title
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Effect of Stroke Volume Variation Guided Fluid Therapy on the Blood Loss and Postoperative Outcomes in Radical Cystectomy

Conditions
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Bladder Cancer

Intervention / Treatment
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* Other: crystalloid
* Other: colloid
* Other: mannitol
* Other: lasix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bladder cancer patients who received radical cystectomy Patients with American Society of Anesthesiologists physical status scale classification 1, 2 Patients who agree with written informed consent Exclusion Criteria: Patients with history of arrhythmia, heart failure patients Patients with history of renal failure patients Patients with history of abdominal surgery Patients who received emergency operation Patients who do not agree with study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (SVV <10% group)<br>infuse crystalloid (Hartmann's solution) 6-10 ml/kg/hr continuously during surgery infuse colloid (Volulyte) 200 ml if SVV is ≥ 10% during the surgery Interventions: crystalloid (Hartmann's solution), colloid (Volulyte) | Other: crystalloid<br>* Group A (SVV <10%): infuse crystalloid 6-10 ml/kg/hr during surgery. Group B (SVV 10-20%): infuse crystalloid 2-4 ml/kg/hr until cystectomy, 6-10 ml/kg/hr after cystectomy<br>* Other names: Hartmann's solution;Other: colloid<br>* Group A (SVV <10%): infuse colloid 200 ml if SVV is ≥ 10%. Group B (SVV 10-20%): infuse colloid 200 ml if SVV is > 20%<br>* Other names: volulyte;|
| Experimental: Group B (SVV 10-20% group)<br>infuse crystalloid (Hartmann's solution) 2-4 ml/kg/hr until cystectomy, 6-10 ml/kg/hr after cystectomy infuse colloid (Volulyte) 200 ml if SVV is > 20% infuse mannitol 0.5 g/kg or lasix 5 mg if SVV < 10% Interventions: crystalloid (Hartmann's solution), colloid (Volulyte), mannitol, lasix | Other: crystalloid<br>* Group A (SVV <10%): infuse crystalloid 6-10 ml/kg/hr during surgery. Group B (SVV 10-20%): infuse crystalloid 2-4 ml/kg/hr until cystectomy, 6-10 ml/kg/hr after cystectomy<br>* Other names: Hartmann's solution;Other: colloid<br>* Group A (SVV <10%): infuse colloid 200 ml if SVV is ≥ 10%. Group B (SVV 10-20%): infuse colloid 200 ml if SVV is > 20%<br>* Other names: volulyte;Other: mannitol<br>* Group B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is < 10%<br>Other: lasix<br>* Group B (SVV 10-20%): infuse lasix 5 mg if SVV is < 10%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss |  | During operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications (cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death) | Postoperative complications include cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death | During 30 days after operation | 
| Length of hospital stay/ICU stay |  | participants will be followed for the duration of hospital stay, an expected average of 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke volume variation, radical cystectomy, blood loss, postoperative complications