Intraoperative HypotensionEarly Phase 1NCT05011357
Phenylephrine and Pulse Pressure Variability
A Early Phase 1 study testing Phenylephrine in people with Intraoperative Hypotension, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to determine how vasopressors affect a measure of how intravenous fluid is administered in people undergoing surgery who have low blood pressure called Pulse Pressure Variability (PPV). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2021to 20 Aug 2024
- Phase
- Early Phase 1
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 45 years of age
- Non-obese (Body Mass Index less than 30 kg/m2)
- Baseline systolic blood pressure between 80-140 mmHg
- Baseline diastolic blood pressure <90 mmHg
Who cannot join
- Participants who have cardiac, vascular, respiratory, neurological and/or metabolic illness
- Current or previous use of anti-hypertensive medications
- Any known history of renal or hepatic insufficiency/disease
- Pregnancy (verified by negative urine test on the experimental days) or breast-feeding
- Current smokers, as well as individuals who regularly smoked within the past 3 years
- Sulfite allergy, as this is a contraindication to intravenous phenylephrine
Show all 11Show fewer
- Serious mental illness including claustrophobia
- History of use of recreational drugs including cocaine or amphetamines
- Peripheral vascular disease
- Subject on anticoagulant treatment
- Subjects with a baseline systolic blood pressure <80 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Phenylephrine Infusion on Pulse Pressure Variability
The purpose of this research study is to determine how vasopressors affect a measure of how intravenous fluid is administered in people undergoing surgery who have low blood pressure called Pulse Pressure Variability (PPV). This study will recruit human subjects to undergo simulated hypovolemia called Lower Body Negative Pressure (LBNP) and will receive phenylephrine and placebo, while PPV will be measured in both conditions. This research will help anesthesiologists learn more about how to use PPV in patients undergoing surgery and who need vasopressors.
Read the detailed description
Perioperative fluid administration is a very important issue in modern anesthesia practice. Overzealous intraoperative administration of fluids can lead to cardiac overload thus potentially causing significant morbidity. It has been demonstrated that over 50% of perioperative complications are tied to intraoperative fluid administration and that changing intraoperative fluid management alone has significant positive benefit. Pulse pressure variation (PPV), which quantifies the respiratory variation in beat-to-beat arterial blood pressure, is viewed as a reliable method to assess volume status. Increasing PPV indicates hypovolemia, and a decreasing PPV indicates progression towards euvolemia. However, there are many commonly encountered intraoperative conditions that may make these interpretations of PPV problematic. For example it is commonly accepted in the perioperative community that PPV is interpretable in patients without vasopressor infusion since there is little consensus to the effects of vasopressor therapy on PPV. Hence the proposed study seeks to characterize the PPV response during simulated hypovolemia with and without infusion of phenylephrine, which acts on alpha-1 receptors to increase systemic vascular resistance, and hence blood pressure.
In a patient under general anesthesia, a PPV cut-off of 13% indicates a positive response to fluid administration. However, this cut-off was based on studies that used a wide variety of vasopressor agents with different mechanisms. Furthermore, it is unclear how effective the current threshold is at predicting fluid responsiveness when vasopressors are added during the same operation (i.e. a PPV of 13% without vasopressors likely represents different physiologic conditions compared to a PPV of 13% with vasopressors in the same operation). Hence, understanding how vasopressors such as phenylephrine change PPV and the PPV threshold is very important and represents an important knowledge gap in the practice of anesthesia.
- Conditions
- Intraoperative Hypotension
- Being tested
- Phenylephrine, Saline Control
- Keywords
- Phenylephrine, Pulse pressure variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called Phenylephrine infusion
Phenylephrine will be administered as an infusion
Saline ControlDrug
Also called Saline
Saline infusion
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Experimental | Phenylephrine infusion (0.3 mcg/kg/hr) Receives: Drug: Phenylephrine |
| Control | Placebo comparator | Saline infusion Receives: Drug: Saline Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Pressure Variability
Quantifying respiratory variation in beat-to-beat arterial blood pressure
Measured: Thirty minutes following phenylephrine infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start10 Sep 2021
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Health Resources
- Responsible party
- Principal investigator, Noah Jouett, University of Texas Southwestern Medical Center
- Investigators
- Noah Jouett, DO/PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011357
- Sponsor's protocol ID
- STU-2021-0497
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2021
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Phenylephrine Infusion on Pulse Pressure Variability
- ClinicalTrials.gov ID
- NCT05011357
- Acronym / sponsor ID
- STU-2021-0497
- Conditions
- Intraoperative Hypotension
- Keywords
- Phenylephrine, Pulse pressure variation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Texas Health Resources
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 18 Aug 2021 (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.
The purpose of this research study is to determine how vasopressors affect a measure of how intravenous fluid is administered in people undergoing surgery who have low blood pressure called Pulse Pressure Variability (PPV). This study will recruit human subjects to undergo simulated hypovolemia called Lower Body Negative Pressure (LBNP) and will receive phenylephrine and placebo, while PPV will be measured in both conditions. This research will help anesthesiologists learn more about how to use PPV in patients undergoing surgery and who need vasopressors.
Detailed description
Perioperative fluid administration is a very important issue in modern anesthesia practice. Overzealous intraoperative administration of fluids can lead to cardiac overload thus potentially causing significant morbidity. It has been demonstrated that over 50% of perioperative complications are tied to intraoperative fluid administration and that changing intraoperative fluid management alone has significant positive benefit. Pulse pressure variation (PPV), which quantifies the respiratory variation in beat-to-beat arterial blood pressure, is viewed as a reliable method to assess volume status. Increasing PPV indicates hypovolemia, and a decreasing PPV indicates progression towards euvolemia. However, there are many commonly encountered intraoperative conditions that may make these interpretations of PPV problematic. For example it is commonly accepted in the perioperative community that PPV is interpretable in patients without vasopressor infusion since there is little consensus to the effects of vasopressor therapy on PPV. Hence the proposed study seeks to characterize the PPV response during simulated hypovolemia with and without infusion of phenylephrine, which acts on alpha-1 receptors to increase systemic vascular resistance, and hence blood pressure.
In a patient under general anesthesia, a PPV cut-off of 13% indicates a positive response to fluid administration. However, this cut-off was based on studies that used a wide variety of vasopressor agents with different mechanisms. Furthermore, it is unclear how effective the current threshold is at predicting fluid responsiveness when vasopressors are added during the same operation (i.e. a PPV of 13% without vasopressors likely represents different physiologic conditions compared to a PPV of 13% with vasopressors in the same operation). Hence, understanding how vasopressors such as phenylephrine change PPV and the PPV threshold is very important and represents an important knowledge gap in the practice of anesthesia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Experimental | Drug: PhenylephrinePhenylephrine infusion (0.3 mcg/kg/hr) |
| Control | Placebo comparator | Drug: Saline ControlSaline infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 45 years of age
- Non-obese (Body Mass Index less than 30 kg/m2)
- Baseline systolic blood pressure between 80-140 mmHg
- Baseline diastolic blood pressure <90 mmHg
Key exclusion criteria (11 listed)
- Participants who have cardiac, vascular, respiratory, neurological and/or metabolic illness
- Current or previous use of anti-hypertensive medications
- Any known history of renal or hepatic insufficiency/disease
- Pregnancy (verified by negative urine test on the experimental days) or breast-feeding
- Current smokers, as well as individuals who regularly smoked within the past 3 years
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: Phenylephrine infusionPhenylephrine will be administered as an infusion | Drug | Phenylephrine |
| Saline ControlAlso: SalineSaline infusion | Drug | Control |
Primary outcome
Pulse Pressure Variability
Time frame: Thirty minutes following phenylephrine infusion
Quantifying respiratory variation in beat-to-beat arterial blood pressure
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 22 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Intraoperative Hypotension
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Carotid Artery Blood Flow, Blood Pressure, and Cardiac Output During Anesthesia in Children Aged 0-5 Years
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Granisetron Use, Blood Pressure, and Nausea and Vomiting During Cesarean Delivery Under Spinal Anesthesia
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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.
Noah Jouett, DO/PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Phenylephrine in people with Intraoperative Hypotension, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 11 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 22 Aug 2024. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Pulse Pressure Variability (time frame: Thirty minutes following phenylephrine infusion). 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 22 Aug 2024.