Bladder CancerNCT02373735
Effect of SVV Guided Fluid Therapy on Blood Loss and Postoperative Outcomes
A study testing crystalloid, colloid and mannitol in people with Bladder Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- crystalloid, colloid and mannitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Stroke Volume Variation 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.
Read the detailed description
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.
- Conditions
- Bladder Cancer
- Being tested
- crystalloid, colloid, mannitol, lasix
- Keywords
- stroke volume variation, radical cystectomy, blood loss, postoperative complications
- Medical subject headings
- Urinary Bladder Neoplasms, Hemorrhage, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crystalloidOther
Also called Hartmann's solution
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
colloidOther
Also called volulyte
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%
mannitolOther
Group B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is < 10%
lasixOther
Group B (SVV 10-20%): infuse lasix 5 mg if SVV is < 10%
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: crystalloid; Other: 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 Receives: Other: crystalloid; Other: colloid; Other: mannitol; Other: lasix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Measured: During operation
Secondary outcomes (2)
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
Measured: During 30 days after operation
Length of hospital stay/ICU stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, Asan Medical Center
- Investigators
- Young-Kug Kim, M.D., Ph.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373735
- Sponsor's protocol ID
- S2014-2192
- Status last verified
- Dec 2015
- First submitted
- 12 Feb 2015
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stroke Volume Variation Guided Fluid Therapy on the Blood Loss and Postoperative Outcomes in Radical Cystectomy
- ClinicalTrials.gov ID
- NCT02373735
- Acronym / sponsor ID
- S2014-2192
- Conditions
- Bladder Cancer
- Keywords
- stroke volume variation, radical cystectomy, blood loss, postoperative complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (SVV <10% group) | Active comparator | Other: crystalloid, Other: colloid* 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) |
| Group B (SVV 10-20% group) | Experimental | Other: crystalloid, Other: colloid, Other: mannitol, Other: lasix* 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 |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| crystalloidAlso: Hartmann's solutionGroup 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 | Group A (SVV <10% group), Group B (SVV 10-20% group) |
| colloidAlso: volulyteGroup 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 | Group A (SVV <10% group), Group B (SVV 10-20% group) |
| mannitolGroup B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is < 10% | Other | Group B (SVV 10-20% group) |
| lasixGroup B (SVV 10-20%): infuse lasix 5 mg if SVV is < 10% | Other | Group B (SVV 10-20% group) |
Primary outcome
Intraoperative blood loss
Time frame: During operation
2 secondary outcomes
Postoperative complications (cardiovascular complications, gastrointestinal complications, pulmonary complications, renal complications, infection, death)
Time frame: During 30 days after operation
Length of hospital stay/ICU stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Kug Kim, M.D., Ph.D principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing crystalloid, colloid and mannitol in people with Bladder Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: During operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.