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NCT Number: NCT02373735

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

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.

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Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemorrhage Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, 138-736, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Hartmann's solution

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%

Other names: volulyte

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%

Primary outcomes

  1. Intraoperative blood loss

    Time frame: During operation

Secondary outcomes

  1. Postoperative complications (cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death)

    Time frame: During 30 days after operation

    Postoperative complications include cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death

  2. Length of hospital stay/ICU stay

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 30 days

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 27, 2015
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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