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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (SVV <10% group) | Active Comparator |
Interventions: crystalloid (Hartmann's solution), colloid (Volulyte) |
|
| Group B (SVV 10-20% group) | Experimental |
Interventions: crystalloid (Hartmann's solution), colloid (Volulyte), mannitol, lasix |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| crystalloid | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative blood loss | During operation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young-Kug Kim, M.D., Ph.D | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D006470 | Hemorrhage |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D000077325 | Ringer's Lactate |
| D003102 | Colloids |
| D008353 | Mannitol |
| D005665 | Furosemide |
| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045424 | Complex Mixtures |
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|
| colloid | Other | 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% |
|
|
| mannitol | Other | Group B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is < 10% |
|
| lasix | Other | Group B (SVV 10-20%): infuse lasix 5 mg if SVV is < 10% |
|
| Length of hospital stay/ICU stay | participants will be followed for the duration of hospital stay, an expected average of 30 days |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004304 |
| Dosage Forms |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |