Arterial HypotensionPhase 4NCT02739399
Effects of Phenylephrine on Cardiac Preload
A Phase 4 study testing Phenylephrine in people with Arterial Hypotension and Anaesthesia, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial summary
In patients under general anesthesia, episodes of hypotension are often treated with phenylephrine. The effect of phenylephrine is conventionally attributed to afterload increase. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arterial Hypotension, Anaesthesia
- What is being tested?
- Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2016to Sep 2016
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- necessity for arterial blood pressure monitoring
- necessity for central venous blood pressure monitoring
Who cannot join
- unwilling or unable to grant written informed consent
- cardiac arrythmia
- contra-indication for phenylephrine
- contra-indications for atropine
- contra-indication for Total Intravenous Anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Dynamic Effects of Phenylephrine on Preload and Cardiac Output in Patients Under General Anaesthesia
In patients under general anesthesia, episodes of hypotension are often treated with phenylephrine. The effect of phenylephrine is conventionally attributed to afterload increase.
The aim of the study is to describe the time course of the effects of phenylephrine on the cardiac preload and cardiac output, and to evaluate whether phenylephrine, as an exclusive alpha-mimetic, could be beneficial for preload optimisation.
Read the detailed description
In consecutive patients scheduled for laparoscopic sigmoidectomy, all hemodynamic and respiratory variables are recorded electronically for subsequent offline analysis.
All patients are ventilated in volume control mode with a tidal volume of 8 ml/kg ideal body weight.
During steady-state Target Controlled Infusion (TCI) propofol/remifentanil anesthesia, when the Mean Arterial Blood Pressure (MAP) dropped below 80% of the awake state for at least 5 minutes, a phenylephrine bolus of 2 μg/kg is administered. If necessary this is repeated, or a continuous administration of phenylephrine is started at a rate of 10-30 μg/kg/u.
All patient manipulations during the procedure are electronically recorded and time stamped for subsequent off-line data analysis.
The first episode in each patient where phenylephrine is administered and in a period of at least 10 minutes when minimal or absent patient manipulation occurred, the hemodynamic variables are analysed to describe the effects of phenylephrine administration on the dynamic preload parameters and macro-hemodynamics.
- Conditions
- Arterial Hypotension, Anaesthesia
- Being tested
- Phenylephrine
- Keywords
- phenylephrine, alpha mimetics, pulse pressure variation, venous return
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called Phenyl
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Patient receiving phenylephrine 2ug/kg | Other | phenylephrine 2ug/kg in case of hypotension Receives: Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
The evolution of the Cardiac Output in a time course <20 minutes after administration
Measured: perioperative
Secondary outcomes (4)
Pulse Pressure Variation
The evolution of Pulse Pressure Variation in a time course <20 minutes
Measured: perioperative
End-Tidal CO2
The evolution of the EtCO2-value in a time course <20 minutes
Measured: perioperative
Arterial Blood Pressure
The evolution of The Arterial Blood Pressure in a time course <20 minutes
Measured: perioperative
central venous pressure
The evolution of the central venous pressure in a time course <20 minutes
Measured: perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypotensionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Alain Kalmar, MD, PhD, Algemeen Ziekenhuis Maria Middelares
- Investigators
- Alain F Kalmar, MD, PhD, Principal investigator, Department of Anaesthesiology and Intensive care medicine, Maria Middelares hospital, Ghent, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739399
- Sponsor's protocol ID
- MM2015.037
- Status last verified
- Dec 2016
- First submitted
- 6 Apr 2016
- Last updated
- 9 Dec 2016
- 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 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dynamic Effects of Phenylephrine on Preload and Cardiac Output in Patients Under General Anaesthesia
- ClinicalTrials.gov ID
- NCT02739399
- Acronym / sponsor ID
- MM2015.037
- Conditions
- Arterial Hypotension, Anaesthesia
- Keywords
- phenylephrine, alpha mimetics, pulse pressure variation, venous return
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Apr 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 patients under general anesthesia, episodes of hypotension are often treated with phenylephrine. The effect of phenylephrine is conventionally attributed to afterload increase.
The aim of the study is to describe the time course of the effects of phenylephrine on the cardiac preload and cardiac output, and to evaluate whether phenylephrine, as an exclusive alpha-mimetic, could be beneficial for preload optimisation.
Detailed description
In consecutive patients scheduled for laparoscopic sigmoidectomy, all hemodynamic and respiratory variables are recorded electronically for subsequent offline analysis.
All patients are ventilated in volume control mode with a tidal volume of 8 ml/kg ideal body weight.
During steady-state Target Controlled Infusion (TCI) propofol/remifentanil anesthesia, when the Mean Arterial Blood Pressure (MAP) dropped below 80% of the awake state for at least 5 minutes, a phenylephrine bolus of 2 μg/kg is administered. If necessary this is repeated, or a continuous administration of phenylephrine is started at a rate of 10-30 μg/kg/u.
All patient manipulations during the procedure are electronically recorded and time stamped for subsequent off-line data analysis.
The first episode in each patient where phenylephrine is administered and in a period of at least 10 minutes when minimal or absent patient manipulation occurred, the hemodynamic variables are analysed to describe the effects of phenylephrine administration on the dynamic preload parameters and macro-hemodynamics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient receiving phenylephrine 2ug/kg | Other | Drug: Phenylephrinephenylephrine 2ug/kg in case of hypotension |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult
- necessity for arterial blood pressure monitoring
- necessity for central venous blood pressure monitoring
Key exclusion criteria (5 listed)
- unwilling or unable to grant written informed consent
- cardiac arrythmia
- contra-indication for phenylephrine
- contra-indications for atropine
- contra-indication for Total Intravenous Anesthesia
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 |
|---|---|---|
| PhenylephrineAlso: PhenylIntravenous administration | Drug | Patient receiving phenylephrine 2ug/kg |
Primary outcome
Cardiac output
Time frame: perioperative
The evolution of the Cardiac Output in a time course <20 minutes after administration
4 secondary outcomes
Pulse Pressure Variation
Time frame: perioperative
End-Tidal CO2
Time frame: perioperative
Arterial Blood Pressure
Time frame: perioperative
central venous pressure
Time frame: perioperative
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 9 Dec 2016.
- Individual participant dataSharing planned: No
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OB VEGA-Phenylephrine vs Norepinephrine Outcomes
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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.
Alain F Kalmar, MD, PhD principal investigator
Department of Anaesthesiology and Intensive care medicine, Maria Middelares hospital, Ghent, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phenylephrine in people with Arterial Hypotension and Anaesthesia, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
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 3 inclusion and 5 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 9 Dec 2016. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cardiac output (time frame: perioperative). 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 9 Dec 2016.