NCT02373735

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 30, 2015

Status Verified

December 1, 2015

Enrollment Period

8 months

First QC Date

February 12, 2015

Last Update Submit

December 28, 2015

Conditions

Bladder Cancer

Keywords

stroke volume variationradical cystectomyblood losspostoperative complications

Outcome Measures

Primary Outcomes (1)

  • Intraoperative blood loss

    During operation

Secondary Outcomes (2)

  • Postoperative complications (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

Study Arms (2)

Group A (SVV <10% group)

ACTIVE COMPARATOR

* 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: crystalloidOther: colloid

Group B (SVV 10-20% group)

EXPERIMENTAL

* 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: crystalloidOther: colloidOther: mannitolOther: lasix

Interventions

crystalloidOTHER

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

Also known as: Hartmann's solution
Group A (SVV <10% group)Group B (SVV 10-20% group)
colloidOTHER

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%

Also known as: volulyte
Group A (SVV <10% group)Group B (SVV 10-20% group)
mannitolOTHER

Group B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is \< 10%

Group B (SVV 10-20% group)
lasixOTHER

Group B (SVV 10-20%): infuse lasix 5 mg if SVV is \< 10%

Group B (SVV 10-20% group)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsHemorrhagePostoperative Complications

Interventions

Crystalloid SolutionsRinger's LactateColloidsMannitolFurosemide

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Isotonic SolutionsSolutionsPharmaceutical PreparationsComplex MixturesDosage FormsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesSulfanilamidesSulfonamidesAmidesAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Young-Kug Kim, M.D., Ph.D

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 27, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

December 30, 2015

Record last verified: 2015-12

Locations

KR(1)