Stroke Volume VariationNCT04388995
SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia
A study testing volume expansion in people with Stroke Volume Variation and Pulse Pressure Variation, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Although individualized or goal-directed approach has been advocated, a reliable index is still required to help monitor the volume status timely and efficiently. Dynamic indexes, such as pulse pressure variation (PPV) and stroke volume variation (SVV), have been shown to be clearly superior to more commonly measured… Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Stroke Volume Variation, Pulse Pressure Variation, Fluid Responsiveness
- What is being tested?
- volume expansion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2020to 31 Aug 2020
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1.Patients undergoing gastrointestinal surgery 2.Age between 18 and 80 3.ASA I ~II. 4.BMI 18 ~ 24 kg/m2
Who cannot join
- 1.arrhythmias 2.intracardiac shunts 3.severe hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) 4.pulmonary hypertension 5.chronic obstructive pulmonary disease 6.peripheral vascular obstructive disease 7.receiving long-term treatment with vasopressors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stroke Volume Variation and Pulse Pressure Variation Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia
Although individualized or goal-directed approach has been advocated, a reliable index is still required to help monitor the volume status timely and efficiently. Dynamic indexes, such as pulse pressure variation (PPV) and stroke volume variation (SVV), have been shown to be clearly superior to more commonly measured static preload variables, such as pulmonary artery occlusion pressure (PAOP) and central venous pressure (CVP). The reliability of dynamic indexes in monitoring the volume status and predicting fluid responsiveness have been validated. Fluid optimization guided by SVV and PPV is beneficial to hemodynamic stability and can decrease mortality and reduce postoperative complications. However, the usefulness of dynamic indexes in elderly patients has not been previously investigated. This study aimed to evaluate whether dynamic indexes PPV and SVV can reliably predict fluid responsiveness in elderly patients, and to determine their thresholds in elderly patients.
- Being tested
- volume expansion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume expansionDiagnostic test
volume expansion with 6% hydroxyethyl starch (7 mL/kg) at a rate of 0.4 mL/kg/min
| Study group | Role | What they receive |
|---|---|---|
| observed patients | Experimental | Not described Receives: Diagnostic Test: volume expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid responsiveness
Fluid responsiveness was defined as an increase in CI ≥15%
Measured: immediately after the fluid therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start12 May 2020
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Volume VariationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Liu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388995
- Sponsor's protocol ID
- PLAGHAOC202002
- Status last verified
- Aug 2020
- First submitted
- 11 May 2020
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Volume Variation and Pulse Pressure Variation Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04388995
- Acronym / sponsor ID
- PLAGHAOC202002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 12 May 2020 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 15 May 2020 (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.
Although individualized or goal-directed approach has been advocated, a reliable index is still required to help monitor the volume status timely and efficiently. Dynamic indexes, such as pulse pressure variation (PPV) and stroke volume variation (SVV), have been shown to be clearly superior to more commonly measured static preload variables, such as pulmonary artery occlusion pressure (PAOP) and central venous pressure (CVP). The reliability of dynamic indexes in monitoring the volume status and predicting fluid responsiveness have been validated. Fluid optimization guided by SVV and PPV is beneficial to hemodynamic stability and can decrease mortality and reduce postoperative complications. However, the usefulness of dynamic indexes in elderly patients has not been previously investigated. This study aimed to evaluate whether dynamic indexes PPV and SVV can reliably predict fluid responsiveness in elderly patients, and to determine their thresholds in elderly patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observed patients | Experimental | Diagnostic Test: volume expansion |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Patients undergoing gastrointestinal surgery 2.Age between 18 and 80 3.ASA I ~II. 4.BMI 18 ~ 24 kg/m2
Key exclusion criteria (1 listed)
- 1.arrhythmias 2.intracardiac shunts 3.severe hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg) 4.pulmonary hypertension 5.chronic obstructive pulmonary disease 6.peripheral vascular obstructive disease 7.receiving long-term treatment with vasopressors.
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 |
|---|---|---|
| volume expansionvolume expansion with 6% hydroxyethyl starch (7 mL/kg) at a rate of 0.4 mL/kg/min | Diagnostic test | observed patients |
Primary outcome
Fluid responsiveness
Time frame: immediately after the fluid therapy
Fluid responsiveness was defined as an increase in CI ≥15%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
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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 volume expansion in people with Stroke Volume Variation and Pulse Pressure Variation, run by Chinese PLA General 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 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 26 Aug 2020. 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?
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: immediately after the fluid therapy). 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 26 Aug 2020.