Phenylephrine for Hypotension

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Texas Southwestern Medical Center, Dallas, TX
Hypotension+1 More
Phenylephrine - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether vasopressors affect a measure of how intravenous fluid is administered in people undergoing surgery who have low blood pressure called Pulse Pressure Variability (PPV).

See full description

Eligible Conditions

  • Hypotension
  • Intra-operative Hypotension

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Phenylephrine will improve 1 primary outcome in patients with Hypotension. Measurement will happen over the course of Thirty minutes following phenylephrine infusion.

Thirty minutes following phenylephrine infusion
Pulse Pressure Variability

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Phenylephrine
1 of 2
Control
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 6 total participants across 2 different treatment groups

This trial involves 2 different treatments. Phenylephrine is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Phenylephrine
Drug
Phenylephrine infusion (0.3 mcg/kg/hr)
Control
Drug
Saline infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phenylephrine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: thirty minutes following phenylephrine infusion
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly thirty minutes following phenylephrine infusion for reporting.

Who is running the study

Principal Investigator
N. J.
Noah Jouett, Resident Anesthesiologist
University of Texas Southwestern Medical Center

Closest Location

University of Texas Southwestern Medical Center - Dallas, TX

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

What are the signs of hypotension?

"The common signs of hypotension, such as cold, pale skin, decreased level of consciousness, slow heart rate, and fast heart rate, can be easily observed in patients recovering from major trauma, often in conjunction with shock. In the present study, an inability of the pulse of the radial artery to be palpable in the emergency department was the most sensitive and specific sign of hypotension, followed by severe respiratory acidosis or respiratory distress." - Anonymous Online Contributor

Unverified Answer

What causes hypotension?

"The use of multiple vasoconstrictives is recommended when treating hypotension in an effort to prevent the occurrence of severe hypotension and the possible need for fluid replacement. This recommendation is not specific to vasopressin use; however, evidence supports use of vasopressin for fluid replacement in acute hypovolemic shock states and may improve mortality and morbidity. In those with severe low blood pressure or shock, the use of vasopressin may also be used at the patient bedside for improving cerebral oxygenation by enhancing cerebral vasodilatation. In the field, it may also help maintain peripheral microvascular perfusion by increasing coronary flow." - Anonymous Online Contributor

Unverified Answer

Can hypotension be cured?

"With good treatment and close monitoring of patients, the incidence of hypophosphatemia may be reduced. However, hypotension is a challenging condition to manage. There are many treatment options with varying levels of evidence, and no guarantee of cure. Treatment should be individualized according to the patient's background and coexisting conditions." - Anonymous Online Contributor

Unverified Answer

How many people get hypotension a year in the United States?

"About 7% of all adults in the United States receive an antihypertensive treatment in a given period of time. We found an increase in hypotension in older people and a significant relationship between hypotension and the use of the most recent antihypertensive medicine." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hypotension?

"Common treatment guidelines for hypovolemic shock include intravenous fluids to increase blood volume and replacement with plasma and colloid solutions; vasopressors are used to decrease vascular resistance to minimize organ hypoperfusion; and in refractory cases, inotropic agents, such as dobutamine, are needed to support cardiac function. Many hypovolemic shock patients require hospitalization." - Anonymous Online Contributor

Unverified Answer

What is hypotension?

"In this nonhypotensive group of patients, pulse oximetry tended to be significantly elevated, while there was a strong inverse relation between pulse oximetry and blood lactate and a positive correlation between pulse oximetry and serum cortisol." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving phenylephrine?

"The first report of an intravenous phenylephrine-free-infusion combination, which is not available in English, was published in 2006, while the first clinical trial on phenylephrine for treatment of hypotension in pregnant women was published in 2013. Further clinical research into possible phenylephrine is necessary." - Anonymous Online Contributor

Unverified Answer

How serious can hypotension be?

"Results from a recent paper, hypotension was classified as mild, moderate, severe, and critical based on arterial blood pressure. The incidence of hypotension was the most significant risk factor for in-hospital and 30-day mortality in patients with traumatic brain injury; critical hypotension was identified as a significant independent predictor of death, even in patients with traumatic brain injury who did not require neurosurgical intervention." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hypotension?

"We find no primary cause of hypotension in this study. Hypovolemia or adrenal insufficiency could also be the cause of hypotension but are not confirmed by this research in this study. Further investigation of other causes of hypotension is required." - Anonymous Online Contributor

Unverified Answer

What is the latest research for hypotension?

"Clinical trials show the benefits of medications, and some medications work better or worse than others. One method for physicians [in reviewing the recent research] is by using a list of medicines suggested, based on a patient's current conditions and preferences. Another important method is to ask the patient's doctor about the newest treatment options, rather than reviewing only the research as a whole. Patients with hypotension should ask their doctor how well each one of their medications fit their condition at that time. The best solution for a chronically hypotensive patient is to find out exactly what the latest research says, and if any of the research indicates a better way to treat their condition." - Anonymous Online Contributor

Unverified Answer

What is phenylephrine?

"There is no evidence to recommend phenylephrine to treat low blood pressure associated with sepsis or the sepsis syndrome. [Cite as : Am J Respiratory Care 2016;94:S25-33. doi:10.1164/ajrc.S25-33.1.01] The majority of trials studied hypotension to a clinically useful end point that was defined as a decrease in mean arterial blood pressure over 2 hour intervals exceeding a threshold of 30% or reduction in the stroke volume to less than 20% of the pretreatment value. In some cases, the authors reported that the phenylephrine was also used in other conditions that have a known vasoconstrictive effect." - Anonymous Online Contributor

Unverified Answer

Is phenylephrine safe for people?

"Phenylephrine is both a practical and cost feasible medication for people with cardiopulmonary emergency and does not increase their risk of death. Phenylephrine use is associated with a small increase in hypotension. A higher dose of phenylephrine (<or = 10 microg) does not enhance treatment success." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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