Phenylephrine and Pulse Pressure Variability
-
- STATUS
- Recruiting
-
- End date
- Jun 30, 2023
-
- participants needed
- 6
-
- sponsor
- University of Texas Southwestern Medical Center
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). 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.
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.
Details
| Condition | Intraoperative Hypotension |
|---|---|
| Treatment | Phenylephrine, Saline control |
| Clinical Study Identifier | NCT05011357 |
| Sponsor | University of Texas Southwestern Medical Center |
| Last Modified on | 25 March 2022 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer