Circulatory FunctionNCT03892031
Circulatory Function in Laparoscopic Radical Cystectomy for Bladder Cancer
An observational study of Circulatory Function and Laparoscopic Radical Cystectomy for Bladder Cancer, run by RenJi Hospital at 1 site in China.
Trial summary
To optimize the perioperative management of patients undergoing laparoscopic radical cystectomy(LPC) for bladder cancer through observation of perioperative changes of Brain Natriuretic Peptide(BNP), stroke volume variation(SVV), central venous pressure(CVP) and the use of transthoracic echocardiography(TTE). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Circulatory Function, Laparoscopic Radical Cystectomy for Bladder Cancer
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Observational
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo laparoscopic radical cystectomy for bladder cancer in Renji Hospital
Who may be able to join
- undergoing laparoscopic radical cystectomy for bladder cancer
- ASA I-II
Who cannot join
- Cardiac insufficiency
- Hepatic insufficiency
- Renal insufficiency
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Preliminary Study on the Changes of Perioperative Circulatory Function in Patients Undergoing Laparoscopic Radical Cystectomy for Bladder Cancer
To optimize the perioperative management of patients undergoing laparoscopic radical cystectomy(LPC) for bladder cancer through observation of perioperative changes of Brain Natriuretic Peptide(BNP), stroke volume variation(SVV), central venous pressure(CVP) and the use of transthoracic echocardiography(TTE).
Read the detailed description
Long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer influence perioperative circulatory function, resulting in a series of pathophysiological changes. BNP is of high sensitivity and specificity in the evaluation of cardiac function. SVV and CVP are dynamic and static indices to predict fluid responsiveness. TTE is a good indicator of volume and cardiac function.Thus, we conducted the trial to assess the perioperative circulatory function in patients undergoing LPC. We hypothesized that long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer would increase perioperative blood volume and influence cardiac function.
- Keywords
- brain natriuretic peptide, pneumoperitoneum, Trendelenburg, circulatory function, laparoscopic radical cystectomy for bladder cancer, central venous pressure, stroke volume variation, transthoracic echocardiography
- Medical subject headings
- Pneumoperitoneum
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Natriuretic Peptide(BNP)
To observe the change of BNP perioperatively.
Measured: before induction (T1), at the end of operation(T2), at 12 hours (T3) and 24 hours (T4) postoperatively
Central Venous Pressure(CVP)
To observe the change of CVP perioperatively.
Measured: before induction (T1),at the end of operation (T2), at 12 hours (T3) and 24 hours (T4) postoperatively
Stroke Volume Variation(SVV)
To observe the change of SVV perioperatively.
Measured: before induction (T1), at the end of operation (T2)
Transthoracic Echocardiography
To observe the change of End-diastolic volume(EDV) perioperatively
Measured: before induction (T1),at the end of operation (T2), at 12 hours (T3) and 24 hours (T4) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory FunctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DAN HUANG, RenJi Hospital
- Investigators
- Jie Chen, MS, Study chair, Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892031
- Sponsor's protocol ID
- Circulatory function in LRC
- Status last verified
- Feb 2022
- First submitted
- 26 Mar 2019
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study on the Changes of Perioperative Circulatory Function in Patients Undergoing Laparoscopic Radical Cystectomy for Bladder Cancer
- ClinicalTrials.gov ID
- NCT03892031
- Acronym / sponsor ID
- Circulatory function in LRC
- Keywords
- brain natriuretic peptide, pneumoperitoneum, Trendelenburg, circulatory function, laparoscopic radical cystectomy for bladder cancer, central venous pressure, stroke volume variation, transthoracic echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Mar 2019 (actual)
- 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.
To optimize the perioperative management of patients undergoing laparoscopic radical cystectomy(LPC) for bladder cancer through observation of perioperative changes of Brain Natriuretic Peptide(BNP), stroke volume variation(SVV), central venous pressure(CVP) and the use of transthoracic echocardiography(TTE).
Detailed description
Long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer influence perioperative circulatory function, resulting in a series of pathophysiological changes. BNP is of high sensitivity and specificity in the evaluation of cardiac function. SVV and CVP are dynamic and static indices to predict fluid responsiveness. TTE is a good indicator of volume and cardiac function.Thus, we conducted the trial to assess the perioperative circulatory function in patients undergoing LPC. We hypothesized that long term pneumoperitoneum and steep trendelenburg in LPC for bladder cancer would increase perioperative blood volume and influence cardiac function.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo laparoscopic radical cystectomy for bladder cancer in Renji Hospital
Key inclusion criteria (2 listed)
- undergoing laparoscopic radical cystectomy for bladder cancer
- ASA I-II
Key exclusion criteria (3 listed)
- Cardiac insufficiency
- Hepatic insufficiency
- Renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Brain Natriuretic Peptide(BNP)
Time frame: before induction (T1), at the end of operation(T2), at 12 hours (T3) and 24 hours (T4) postoperatively
To observe the change of BNP perioperatively.
Central Venous Pressure(CVP)
Time frame: before induction (T1),at the end of operation (T2), at 12 hours (T3) and 24 hours (T4) postoperatively
To observe the change of CVP perioperatively.
Stroke Volume Variation(SVV)
Time frame: before induction (T1), at the end of operation (T2)
To observe the change of SVV perioperatively.
Transthoracic Echocardiography
Time frame: before induction (T1),at the end of operation (T2), at 12 hours (T3) and 24 hours (T4) postoperatively
To observe the change of End-diastolic volume(EDV) perioperatively
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 17 Feb 2022.
Related trials for Circulatory Function
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
Acute Stroke, Upper Limb Motor Deficit
Recruiting
Hemodynamics After Resistance Training
Perimenopause
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.
Jie Chen, MS study chair
Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulatory Function and Laparoscopic Radical Cystectomy for Bladder Cancer, run by RenJi Hospital at 1 site in China.
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 3 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 17 Feb 2022. 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 China. 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?
Brain Natriuretic Peptide(BNP) (time frame: before induction (T1), at the end of operation(T2), at 12 hours (T3) and 24 hours (T4) postoperatively). The study lists 4 primary outcomes in all. 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 17 Feb 2022.