Vasopressors for Low Blood Pressure

(V-SPINE Trial)

Overseen By Farzin Ahmed, MPH

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Pregnancy, Dialysis, Recent cardiac issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: During inpatient admission

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized control trial comparing norepinephrine versus phenylephrine for vasopressor support in patients undergoing elective spinal fusion surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Norepinephrine for treating low blood pressure?

Research shows that norepinephrine is used to manage low blood pressure in various situations, such as during surgeries or in preterm neonates, by improving blood pressure and cardiac output (the amount of blood the heart pumps). Phenylephrine, another component of the treatment, is known to elevate blood pressure by stimulating certain receptors in the body. ^{1 2 3 4 5}

Is norepinephrine or phenylephrine generally safe for treating low blood pressure?

Norepinephrine and phenylephrine are generally considered safe for managing low blood pressure, especially during procedures like cesarean sections. Norepinephrine is associated with fewer side effects like bradycardia (slow heart rate) compared to phenylephrine, which can cause severe hypertension (high blood pressure) and, in rare cases, pulmonary edema (fluid in the lungs) if not used carefully. ^{2 3 6 7 8}

How does the drug used in the Vasopressors for Low Blood Pressure trial differ from other treatments?

Vasopressors, like norepinephrine, are unique because they are specifically designed to quickly increase blood pressure in emergency situations by improving blood flow to vital organs. Unlike other treatments, they are titratable, meaning their dosage can be adjusted based on the patient's response, and they are often used in combination with other vasopressors to achieve optimal blood pressure control. ^{1 3 4 9 10}

Research Team

Siddharth Dave, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This clinical trial is for adults over 18 years old who are scheduled to have elective spinal fusion surgery while lying face down. Specific details about who can't join the trial are not provided.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either norepinephrine or phenylephrine for vasopressor support during elective spinal fusion surgery

During inpatient admission

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on postoperative outcomes such as acute kidney injury, myocardial injury, and lactate elevation

During inpatient admission

Treatment Details

Interventions

• Norepinephrine
• Phenylephrine

Trial Overview The study is testing two medications, Norepinephrine and Phenylephrine, to see which one is better at supporting blood pressure during elective spine surgery. Patients will be randomly assigned to receive one of these drugs.

Participant Groups

Group I: Norepinephrine Active Control 1 Intervention

Patients receiving norepinephrine for intraoperative hypotension

Group II: Phenylephrine Active Control 1 Intervention

Patients receiving phenylephrine for intraoperative hypotension

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

In a study of 86 pre-eclamptic women undergoing cesarean sections, both phenylephrine and norepinephrine were found to be equally effective in treating postspinal hypotension, with no significant differences in neonatal outcomes as measured by umbilical artery pH.

However, the phenylephrine group experienced fewer hypotensive episodes and lower heart rates compared to the norepinephrine group, suggesting it may be a safer option in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised double-blind comparison of phenylephrine and norepinephrine for the management of postspinal hypotension in pre-eclamptic patients undergoing caesarean section. Mohta, M., R, L., Chilkoti, GT., et al.[2022]

In a study of 52 patients with essential hypertension (EH), urinary levels of conjugated norepinephrine were found to be higher in both borderline and sustained EH compared to normal individuals, suggesting altered sympathetic nervous system activity in these patients.

Clonidine effectively lowered blood pressure and plasma norepinephrine levels in patients with sustained EH, indicating its potential as a treatment option, while it had little effect on borderline EH, highlighting differences in sympathetic nervous system responsiveness between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Studies on the role of the central and peripheral sympathetic nervous system and the renin-aldosterone system on the onset and maintenance of high blood pressure in essential hypertension]. Shigetomi, S.[2019]

Hypertensive patients should avoid using adrenergic agents for blood pressure control, with nasal phenylephrine hydrochloride being the safest option among them, while pseudoephedrine may also be safe.

Ibuprofen can raise blood pressure if taken at maximum over-the-counter doses for extended periods, highlighting the need for caution with nonprescription medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonprescription drugs and hypertension. Which ones affect blood pressure? Bradley, JG.[2019]

Sympathomimetic decongestants, commonly found in cold medications, can raise blood pressure, which poses a risk for patients with hypertension.

Due to the potential for adverse effects, particularly with agents like phenylephrine and pseudoephedrine, it is advisable for individuals with high blood pressure to avoid these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drugs for cough and cold symptoms in hypertensive patients. White, WB., Riotte, K.[2013]

Preterm neonates often experience hypotension, and while various vasoactive medications are used to support their cardiovascular health, the understanding of how these medications affect blood pressure and circulation in this population is limited.

This review highlights the pharmacologic actions and potential side effects of commonly used antihypotensive medications like dopamine and epinephrine, emphasizing the need for careful consideration when applying findings from other studies to preterm neonates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating Hypotension in Preterm Neonates With Vasoactive Medications. Joynt, C., Cheung, PY.[2020]

Norepinephrine significantly reduces the incidence of bradycardia and reactive hypertension compared to phenylephrine in pregnant women undergoing elective cesarean delivery under spinal anesthesia, based on a systematic review of 12 studies.

Both norepinephrine and phenylephrine show similar rates of hypotension, nausea, and vomiting, indicating that norepinephrine is a safe and effective alternative for maintaining blood pressure without adverse effects on maternal or fetal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of prophylactic norepinephrine and phenylephrine in spinal anesthesia for cesarean section: A systematic review and meta-analysis with trial sequential analysis. Liu, P., He, H., Zhang, SS., et al.[2022]

Topical phenylephrine can cause severe hypertension due to its action on alpha-adrenergic receptors, which is a significant safety concern, especially in pediatric patients.

In this case, a pediatric patient experienced acute pulmonary edema after receiving a large dose of phenylephrine followed by beta-blockers, highlighting the potential risks of combining these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary edema following phenylephrine intranasal spray administration during the induction of general anesthesia in a child. Son, JS., Lee, SK.[2022]

In a study of 166 parturient women with preeclampsia experiencing hypotension during cesarean delivery, bolus norepinephrine was found to be as effective as phenylephrine in managing blood pressure, while also enhancing maternal and neonatal safety.

Norepinephrine resulted in fewer episodes of bradycardia and tachycardia compared to phenylephrine and ephedrine, indicating a safer profile for use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Study of Bolus Norepinephrine, Phenylephrine, and Ephedrine for the Treatment of Maternal Hypotension in Parturients with Preeclampsia During Cesarean Delivery Under Spinal Anesthesia. Wang, X., Mao, M., Liu, S., et al.[2020]

Vasopressors are critical medications used to increase blood pressure in emergencies, with norepinephrine being a preferred choice for conditions like cardiogenic and septic shock due to its effectiveness in maintaining organ perfusion.

Current evidence does not show a clear mortality benefit for any specific vasopressor over others, indicating that the choice of vasopressor often depends on clinical circumstances and physician preference.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vasopressor use in adult patients. Ferguson-Myrthil, N.[2013]

Norepinephrine (NE) is recommended as the first-line vasopressor for treating septic shock-induced hypotension, as it helps quickly achieve target mean arterial pressure (MAP) and reduces the risk of fluid overload.

While vasopressin and its analogues are considered second-line options, combining NE with other vasopressors may be beneficial for patients with refractory hypotension to reach MAP targets or lower NE dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vasopressors in septic shock: which, when, and how much? Shi, R., Hamzaoui, O., De Vita, N., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

A randomised double-blind comparison of phenylephrine and norepinephrine for the management of postspinal hypotension in pre-eclamptic patients undergoing caesarean section. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

[Studies on the role of the central and peripheral sympathetic nervous system and the renin-aldosterone system on the onset and maintenance of high blood pressure in essential hypertension]. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Nonprescription drugs and hypertension. Which ones affect blood pressure? [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Drugs for cough and cold symptoms in hypertensive patients. [2013]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Treating Hypotension in Preterm Neonates With Vasoactive Medications. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of prophylactic norepinephrine and phenylephrine in spinal anesthesia for cesarean section: A systematic review and meta-analysis with trial sequential analysis. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Pulmonary edema following phenylephrine intranasal spray administration during the induction of general anesthesia in a child. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A Comparative Study of Bolus Norepinephrine, Phenylephrine, and Ephedrine for the Treatment of Maternal Hypotension in Parturients with Preeclampsia During Cesarean Delivery Under Spinal Anesthesia. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Vasopressor use in adult patients. [2013]

10. China pubmed.ncbi.nlm.nih.gov

Vasopressors in septic shock: which, when, and how much? [2020]