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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two medications, norepinephrine and phenylephrine, which raise low blood pressure. It focuses on individuals undergoing scheduled spinal fusion surgery while lying face-down. The researchers aim to determine which medication better stabilizes blood pressure during surgery. Suitable candidates are those over 18 planning this specific back surgery, without severe kidney issues or recent heart problems. As an Early Phase 1 trial, this research seeks to understand how these treatments work in people, offering participants a chance to contribute to groundbreaking medical knowledge.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both norepinephrine and phenylephrine are safe for managing low blood pressure during surgeries. Studies have found that norepinephrine, which stabilizes blood pressure during surgery, does not cause significant side effects when used carefully. In one study, patients given norepinephrine maintained an average blood pressure of 120/75 mm Hg without major safety concerns.

Phenylephrine also effectively prevents low blood pressure during procedures like cesarean sections, and studies have shown no major safety issues with its use. Both drugs are commonly used in surgeries, and current research supports their safety when used as directed. Overall, both treatments are well-tolerated, with no significant safety issues reported in the reviewed studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about norepinephrine and phenylephrine for treating low blood pressure during surgery because they offer different mechanisms for stabilizing blood pressure compared to standard treatments. Norepinephrine works by stimulating both alpha and beta-adrenergic receptors, leading to increased heart rate and blood vessel constriction, while phenylephrine primarily targets alpha-adrenergic receptors, causing blood vessels to constrict without significantly affecting heart rate. This distinction allows for more tailored approaches to managing blood pressure, which could lead to better outcomes for patients with varying cardiovascular needs.

What evidence suggests that this trial's treatments could be effective for low blood pressure during spinal fusion surgery?

This trial will compare the effectiveness of norepinephrine and phenylephrine in managing low blood pressure during surgery. Studies have shown that norepinephrine helps maintain stable blood pressure, with one study reporting an average reading of 120 mm Hg, indicating its ability to keep blood pressure steady. Participants in this trial may receive norepinephrine for intraoperative hypotension. Phenylephrine, another treatment option in this trial, is sometimes preferred for preventing low blood pressure after spinal anesthesia, especially in certain types of surgeries. Both medications work similarly well in preventing drops in blood pressure during procedures. ^{1 2 3 5 6}

Who Is on the Research Team?

Siddharth Dave, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34872102/

A Safety and Feasibility Pilot Randomized Controlled Trial The average intraoperative systolic blood pressure was 120 ± 12.6 mm Hg in the norepinephrine group and 115 ± 14.9 mm Hg in the placebo group.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0007091225001953

Continuous versus bolus norepinephrine administration to ... This RCT tested the hypothesis that giving norepinephrine via infusion vs repeated manual boluses reduces hypotension within 15 min of inducing general ...

3. bjanaesthesia.org bjanaesthesia.org/article/S0007-0912(24)00671-8/fulltext

Association of intraoperative hypotension and cumulative ... The risk of developing postoperative AKI would thus increase by 16% if norepinephrine was given at 0.076 μg kg−1 min−1 for 132 min (the median duration of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01536470

Intraoperative Noradrenaline to Control Arterial Pressure ... The purpose of this study is to evaluate whether a preventive strategy of intraoperative arterial hypotension using noradrenaline can reduce the incidence of ...

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-023-04360-w

Effect of intravenous low-dose norepinephrine on blood ... In non-tourniquet TKA under general anesthesia, low-dose intravenous NE safely and effectively reduced intraoperative blood loss and provided a satisfactory ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12513051/

Early Use of Norepinephrine in High-risk Patients Undergoing ... The longer and deeper the intraoperative hypotension, the greater the risk of adverse outcomes. There is ongoing debate regarding the optimal mean arterial ...