CirculationNCT02201121
Influences of Phenylephrine, Dopamine and Ephedrine on Stroke Volume Variation and Pulse Pressure Variation
A study testing Influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variation in people with Circulation and Drug Dose, run by Chinese PLA General Hospital.
Trial summary
Although induced hypertension decreased SVV and PPV,the influences of stroke volume variation and pulse pressure variation caused by phenylephrine,dopamine and ephedrine were unknown. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Circulation, Drug Dose, Calculated SAP
- What is being tested?
- Influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Jun 2014
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Their American Society of Anesthesiologists (ASA) physical status was 1 or 2
- Body mass index (BMI) ranged from 18 to 26
- None of the patients had known diabetes mellitus, hypertension, cardiovascular, pulmonary, endocrinological, neurological diseases, or diseases that influenced intravascular fluid volume or balance
- All patients had a preoperative fast for at least 8 h and routine atropine intramuscular injection
Who cannot join
- Persistent arrhythmias
- Intraoperative application of vasoactive drugs except phenylephrine, dopamine and ephedrine
About this study
Although induced hypertension decreased SVV and PPV,the influences of stroke volume variation and pulse pressure variation caused by phenylephrine,dopamine and ephedrine were unknown.
Read the detailed description
Pulse pressure variation (PPV) and stroke volume variation (SVV) during mechanical ventilation have been shown to be effective parameters to predict preload responsiveness. Although induced hypertension decreases PPV and SVV, the influences of phenylephrine, dopamine and ephedrine on PPV and SVV are unknown.
- Conditions
- Circulation, Drug Dose, Calculated SAP
- Being tested
- Influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variationOther
This research mainly study the effect of clinical commonly used vasoconstrictor drugs on blood pressure of pressure
| Study group | Role | What they receive |
|---|---|---|
| phenylephrine group, dopamine group, ephedrine group | Experimental | phenylephrine group: use the phenylephrine to increase the SAP from low to high level.
dopamine group: use the dopamine to increase the SAP from low to high level. ephedrine group:use the ephedrine to increase the SAP from low to high level. Receives: Other: Influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variation |
What is being measured
The primary outcome is the main question the study is designed to answer.
invasive arterial blood pressure as a Measure of Safety
if instability of circulation, stop the clinical trial
Measured: DAY 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirculationStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ran Kong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201121
- Sponsor's protocol ID
- plaghran001
- Status last verified
- Oct 2013
- First submitted
- 22 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of Phenylephrine, Dopamine and Ephedrine on Stroke Volume Variation and Pulse Pressure Variation
- ClinicalTrials.gov ID
- NCT02201121
- Acronym / sponsor ID
- plaghran001
- Conditions
- Circulation, Drug Dose, Calculated SAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Jul 2014 (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.
Although induced hypertension decreased SVV and PPV,the influences of stroke volume variation and pulse pressure variation caused by phenylephrine,dopamine and ephedrine were unknown.
Detailed description
Pulse pressure variation (PPV) and stroke volume variation (SVV) during mechanical ventilation have been shown to be effective parameters to predict preload responsiveness. Although induced hypertension decreases PPV and SVV, the influences of phenylephrine, dopamine and ephedrine on PPV and SVV are unknown.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| phenylephrine group, dopamine group, ephedrine group | Experimental | Other: Influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variationphenylephrine group: use the phenylephrine to increase the SAP from low to high level. dopamine group: use the dopamine to increase the SAP from low to high level. ephedrine group:use the ephedrine to increase the SAP from low to high level. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Their American Society of Anesthesiologists (ASA) physical status was 1 or 2
- Body mass index (BMI) ranged from 18 to 26
- None of the patients had known diabetes mellitus, hypertension, cardiovascular, pulmonary, endocrinological, neurological diseases, or diseases that influenced intravascular fluid volume or balance
- All patients had a preoperative fast for at least 8 h and routine atropine intramuscular injection
Key exclusion criteria (2 listed)
- Persistent arrhythmias
- Intraoperative application of vasoactive drugs except phenylephrine, dopamine and ephedrine
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 |
|---|---|---|
| Influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variationThis research mainly study the effect of clinical commonly used vasoconstrictor drugs on blood pressure of pressure | Other | phenylephrine group, dopamine group, ephedrine group |
Primary outcome
invasive arterial blood pressure as a Measure of Safety
Time frame: DAY 1
if instability of circulation, stop the clinical trial
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 25 Jul 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variation in people with Circulation and Drug Dose, run by Chinese PLA General Hospital.
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 4 inclusion and 2 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 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
invasive arterial blood pressure as a Measure of Safety (time frame: DAY 1). 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 25 Jul 2014.