Fluid ResponsivenessNCT04030221
Pressure Gradient for Venous Return in Predicting Fluid Responsiveness in Patients Undergoing Laparoscopic Surgery
An observational study of Fluid Responsiveness, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Surgical patients, especially those with insufficient blood volume and hypotension, often need fluid therapy. However, there is still a lack of simple and reliable indicators for judging transfusion responsiveness in some types of surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Responsiveness
- What is being tested?
- fluid infusion
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2019to 20 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing laparoscopic surgery and general anesthesia
Who may be able to join
- patients undergoing laparoscopic surgery and general anesthesia
Who cannot join
- cardiac insufficiency; severe arrhythmias; patients using intra-aortic balloon pump; use of left ventricular assist devices; spasm of peripheral arteries caused by some factor
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: The Pressure Gradient for Venous Return (PVR) in Predicting Fluid Responsiveness in Patients Undergoing Laparoscopic Surgery
Surgical patients, especially those with insufficient blood volume and hypotension, often need fluid therapy. However, there is still a lack of simple and reliable indicators for judging transfusion responsiveness in some types of surgery. Previous studies have shown that Pressure Gradient for Venous Return (PVR) can be used to guide infusion. Thus, our aim is to explore the relationship between PVR and liquid reactivity.
Read the detailed description
Fluid resuscitation is one of the key issues in the management of surgery and anesthesia. Fluid infusion test is a method to determine patients' reactivity to liquid therapy. The commonly used Stroke Volume Variation (SVV) and Pulse Pressure Variation (PPV) are good predictors of fluid responsiveness, but they are not suitable for operations with increased intra-abdominal pressure, such as laparoscopy surgery. Some studies have shown that Pressure Gradient for Venous Return (PVR) may has the same effect as PPV/SVV in predicting fluid responsiveness (FR). In the case that PPV/SVV cannot be used, PVR may be used alternatively. Therefore, our aim is to explore the relationship between the changes of PVR and fluid responsiveness during liquid infusion and to determine relevant parameters.
We will choose patients planed to receive laparoscopic surgery and general anesthesia, especially the patients with gastrointestinal tumors because of generally long operation time and much infusion volume. In our hospital, these patients will routinely indwelled arterial catheters and deep venous catheters during the operation. The former is mainly used to monitor direct arterial pressure, and the latter is used for fluid infusion.Through the above two pathways, we can collect the hemodynamic parameters of patients, and then establish the relationship between PVR and FR.
In our study, a good FR was defined as a 10% increase in cardiac index (CI) after fluid infusion, and PVR is calculated by a special formula based on some specific parameters of hemodynamics.
- Conditions
- Fluid Responsiveness
- Being tested
- fluid infusion
- Keywords
- the pressure gradient for venous return, fluid responsiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid infusionOther
250 ml of liquid will be given within 10 minutes for each patients, and the hemodynamic parameters before and after fluid infusion will be recorded. Then the experiment is completed.
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic parameters
direct arterial pressure including systolic, diastolic and mean arterial pressure; central venous pressure.These data are collected continuously and dynamically.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start20 Jul 2019 (estimated)
- Primary completion20 Aug 2019 (estimated)
- Study completion20 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivenessStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Min, Doctor, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030221
- Sponsor's protocol ID
- 2019-153
- Status last verified
- Jul 2019
- First submitted
- 19 Jul 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pressure Gradient for Venous Return (PVR) in Predicting Fluid Responsiveness in Patients Undergoing Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT04030221
- Acronym / sponsor ID
- 2019-153
- Conditions
- Fluid Responsiveness
- Keywords
- the pressure gradient for venous return, fluid responsiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Jul 2019 (estimated)
- Primary completion
- 20 Aug 2019 (estimated)
- Study completion
- 20 Aug 2019 (estimated)
- First posted
- 23 Jul 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.
Surgical patients, especially those with insufficient blood volume and hypotension, often need fluid therapy. However, there is still a lack of simple and reliable indicators for judging transfusion responsiveness in some types of surgery. Previous studies have shown that Pressure Gradient for Venous Return (PVR) can be used to guide infusion. Thus, our aim is to explore the relationship between PVR and liquid reactivity.
Detailed description
Fluid resuscitation is one of the key issues in the management of surgery and anesthesia. Fluid infusion test is a method to determine patients' reactivity to liquid therapy. The commonly used Stroke Volume Variation (SVV) and Pulse Pressure Variation (PPV) are good predictors of fluid responsiveness, but they are not suitable for operations with increased intra-abdominal pressure, such as laparoscopy surgery. Some studies have shown that Pressure Gradient for Venous Return (PVR) may has the same effect as PPV/SVV in predicting fluid responsiveness (FR). In the case that PPV/SVV cannot be used, PVR may be used alternatively. Therefore, our aim is to explore the relationship between the changes of PVR and fluid responsiveness during liquid infusion and to determine relevant parameters.
We will choose patients planed to receive laparoscopic surgery and general anesthesia, especially the patients with gastrointestinal tumors because of generally long operation time and much infusion volume. In our hospital, these patients will routinely indwelled arterial catheters and deep venous catheters during the operation. The former is mainly used to monitor direct arterial pressure, and the latter is used for fluid infusion.Through the above two pathways, we can collect the hemodynamic parameters of patients, and then establish the relationship between PVR and FR.
In our study, a good FR was defined as a 10% increase in cardiac index (CI) after fluid infusion, and PVR is calculated by a special formula based on some specific parameters of hemodynamics.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing laparoscopic surgery and general anesthesia
Key inclusion criteria (1 listed)
- patients undergoing laparoscopic surgery and general anesthesia
Key exclusion criteria (1 listed)
- cardiac insufficiency; severe arrhythmias; patients using intra-aortic balloon pump; use of left ventricular assist devices; spasm of peripheral arteries caused by some factor
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 infusion250 ml of liquid will be given within 10 minutes for each patients, and the hemodynamic parameters before and after fluid infusion will be recorded. Then the experiment is completed. | Other | – |
Primary outcome
hemodynamic parameters
Time frame: At enrollment
direct arterial pressure including systolic, diastolic and mean arterial pressure; central venous pressure.These data are collected continuously and dynamically.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
Yan Min, Doctor study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Fluid Responsiveness, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Min, Doctor (+86-13757118632, zryanmin@ziu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemodynamic parameters (time frame: At enrollment). 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 23 Jul 2019.