Prostatic NeoplasmNCT02977143
Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery
A study testing Fluid loading of volulyte 300 ml in people with Prostatic Neoplasm and Urinary Bladder Neoplasm, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid… Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm, Urinary Bladder Neoplasm
- What is being tested?
- Fluid loading of volulyte 300 ml
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2016to Mar 2017
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient undergoing robot-assisted laparoscopic radical prostatectomy or cystectomy.
- American Society of Anesthesiologist Physical Status Classification of 1, 2 or 3.
Who cannot join
- Medical history of arrhythmia or new-onset arrhythmia after anesthesia induction.
- Valvular or ischemic heart disease or left ventricular ejection fraction less than 40%.
- Any significant pulmonary disease or history of chronic obstructive pulmonary disease
- End-stage renal disease or preoperative creatinine > 1.4 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Positive End-expiratory Pressure-induced Increase in Central Venous Pressure and Stroke Volume Variation to Predict Fluid Responsiveness in Robot-assisted Laparoscopic Surgery: A Prospective Clinical Trial
In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients. The authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.
Read the detailed description
In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. As a preload index, the predictability of central venous pressure, pulse pressure variation and stroke volume variations may be impaired due to the impaired hemodynamics that result from the effect of increased abdominal pressure and decreased venous return. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients. Therefore, the authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.
- Conditions
- Prostatic Neoplasm, Urinary Bladder Neoplasm
- Being tested
- Fluid loading of volulyte 300 ml
- Keywords
- fluid responsiveness, central venous pressure, positive end-expiratory pressure, robot surgery
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid loading of volulyte 300 mlProcedure or surgery
Administration of volulyte 300 ml and measurement of increase in cardiac index
| Study group | Role | What they receive |
|---|---|---|
| Fluid responsiveness test | Experimental | First, apply 10 cmH2O positive endexpiratory pressure (PEEP) and measure the increase in central venous pressure (CVP) as well as other preload indexes (central venous pressure, mean arterial pressure, stroke volume variation).
Second, measure the increase in cardiac index after administration of volulyte 300 ml.
If cardiac index increase more than 10%, fluid responsiveness is confirmed. Receives: Procedure: Fluid loading of volulyte 300 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid responsiveness
fluid responsiveness is determined when increase in cardiac index is more than 10%
Measured: 5 minutes after administration of 300 ml volulyte
Secondary outcomes (22)
central venous pressure
T1: baseline measurement of central venous pressure with positive end-expiratory pressure of zero
Measured: one hour after the initiation of pneumoperitoneum
cardiac index
T1: baseline measurement of cardiac index with positive end-expiratory pressure of zero
Measured: one hour after the initiation of pneumoperitoneum
stroke volume variation
T1: baseline measurement of stroke volume variation with positive end-expiratory pressure of zero
Measured: one hour after the initiation of pneumoperitoneum
abdominal pressure
T1: baseline measurement of abdominal pressure with positive end-expiratory pressure of zero
Measured: one hour after the initiation of pneumoperitoneum
central venous pressure
T2: measurement of positive end-expiratory pressure-induce increase in central venous pressure
Measured: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
cardiac index
T2: measurement of cardiac index
Measured: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
stroke volume variation
T2: measurement of stroke volume variation
Measured: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
abdominal pressure
T2: measurement of abdominal pressure
Measured: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
central venous pressure
T3: second baseline measurement of central venous pressure with positive end-expiratory pressure of zero
Measured: 5 minutes after removal of positive end-expiratory pressure
cardiac index
T3: second baseline measurement of cardiac index with positive end-expiratory pressure of zero
Measured: 5 minutes after removal of positive end-expiratory pressure
stroke volume variation
T3: second baseline measurement of stroke volume variation with positive end-expiratory pressure of zero
Measured: 5 minutes after removal of positive end-expiratory pressure
abdominal pressure
T3: second baseline measurement of abdominal pressure with positive end-expiratory pressure of zero
Measured: 5 minutes after removal of positive end-expiratory pressure
central venous pressure
measurement of central venous pressure after fluid administration
Measured: T4: 5 minutes after administration of volulyte 300 ml
cardiac index
measurement of cardiac index after fluid administration
Measured: T4: 5 minutes after administration of volulyte 300 ml
stroke volume variation
measurement of stroke volume variation after fluid administration
Measured: T4: 5 minutes after administration of volulyte 300 ml
abdominal pressure
measurement of abdominal pressure after fluid administration
Measured: T4: 5 minutes after administration of volulyte 300 ml
arterial oxygen partial pressure (mmHg)
arterial blood gas analysis
Measured: 5 minutes after anesthesia induction
arterial carbon dioxide partial pressure (mmHg)
arterial blood gas analysis
Measured: 5 minutes after anesthesia induction
arterial oxygen partial pressure (mmHg)
arterial blood gas analysis
Measured: 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O
arterial carbon dioxide partial pressure (mmHg)
arterial blood gas analysis
Measured: 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O
arterial oxygen partial pressure (mmHg)
arterial blood gas analysis
Measured: 1 minutes after the start of skin closure
arterial carbon dioxide partial pressure (mmHg)
arterial blood gas analysis
Measured: 1 minutes after the start of skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ho Kim, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977143
- Sponsor's protocol ID
- 1609-101-793
- Status last verified
- Apr 2018
- First submitted
- 27 Nov 2016
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Positive End-expiratory Pressure-induced Increase in Central Venous Pressure and Stroke Volume Variation to Predict Fluid Responsiveness in Robot-assisted Laparoscopic Surgery: A Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT02977143
- Acronym / sponsor ID
- 1609-101-793
- Conditions
- Prostatic Neoplasm, Urinary Bladder Neoplasm
- Keywords
- fluid responsiveness, central venous pressure, positive end-expiratory pressure, robot surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 30 Nov 2016 (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.
In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients. The authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.
Detailed description
In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload and cardiac output is important for clinical prognosis. As a preload index, the predictability of central venous pressure, pulse pressure variation and stroke volume variations may be impaired due to the impaired hemodynamics that result from the effect of increased abdominal pressure and decreased venous return. Previous studies reported the positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP) could be a accurate predictor of fluid responsiveness in cardiac surgical patients. Therefore, the authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluid responsiveness test | Experimental | Procedure: Fluid loading of volulyte 300 mlFirst, apply 10 cmH2O positive endexpiratory pressure (PEEP) and measure the increase in central venous pressure (CVP) as well as other preload indexes (central venous pressure, mean arterial pressure, stroke volume variation). Second, measure the increase in cardiac index after administration of volulyte 300 ml. If cardiac index increase more than 10%, fluid responsiveness is confirmed. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patient undergoing robot-assisted laparoscopic radical prostatectomy or cystectomy.
- American Society of Anesthesiologist Physical Status Classification of 1, 2 or 3.
Key exclusion criteria (4 listed)
- Medical history of arrhythmia or new-onset arrhythmia after anesthesia induction.
- Valvular or ischemic heart disease or left ventricular ejection fraction less than 40%.
- Any significant pulmonary disease or history of chronic obstructive pulmonary disease
- End-stage renal disease or preoperative creatinine > 1.4 mg/dl
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 |
|---|---|---|
| Fluid loading of volulyte 300 mlAdministration of volulyte 300 ml and measurement of increase in cardiac index | Procedure or surgery | Fluid responsiveness test |
Primary outcome
fluid responsiveness
Time frame: 5 minutes after administration of 300 ml volulyte
fluid responsiveness is determined when increase in cardiac index is more than 10%
22 secondary outcomes
central venous pressure
Time frame: one hour after the initiation of pneumoperitoneum
cardiac index
Time frame: one hour after the initiation of pneumoperitoneum
stroke volume variation
Time frame: one hour after the initiation of pneumoperitoneum
abdominal pressure
Time frame: one hour after the initiation of pneumoperitoneum
central venous pressure
Time frame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
cardiac index
Time frame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
stroke volume variation
Time frame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
abdominal pressure
Time frame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
central venous pressure
Time frame: 5 minutes after removal of positive end-expiratory pressure
cardiac index
Time frame: 5 minutes after removal of positive end-expiratory pressure
stroke volume variation
Time frame: 5 minutes after removal of positive end-expiratory pressure
abdominal pressure
Time frame: 5 minutes after removal of positive end-expiratory pressure
central venous pressure
Time frame: T4: 5 minutes after administration of volulyte 300 ml
cardiac index
Time frame: T4: 5 minutes after administration of volulyte 300 ml
stroke volume variation
Time frame: T4: 5 minutes after administration of volulyte 300 ml
abdominal pressure
Time frame: T4: 5 minutes after administration of volulyte 300 ml
arterial oxygen partial pressure (mmHg)
Time frame: 5 minutes after anesthesia induction
arterial carbon dioxide partial pressure (mmHg)
Time frame: 5 minutes after anesthesia induction
arterial oxygen partial pressure (mmHg)
Time frame: 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O
arterial carbon dioxide partial pressure (mmHg)
Time frame: 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O
arterial oxygen partial pressure (mmHg)
Time frame: 1 minutes after the start of skin closure
arterial carbon dioxide partial pressure (mmHg)
Time frame: 1 minutes after the start of skin closure
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 3 Apr 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid loading of volulyte 300 ml in people with Prostatic Neoplasm and Urinary Bladder Neoplasm, run by Seoul National University Hospital 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 2 inclusion and 4 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 3 Apr 2018. 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?
fluid responsiveness (time frame: 5 minutes after administration of 300 ml volulyte). 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 3 Apr 2018.