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Norepinephrine for Low Blood Pressure (V-SPINE Trial)

Phase < 1

Recruiting

Led By Siddharth Dave, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

-Patients > 18 years undergoing elective, prone, spinal fusion surgery

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during inpatient admission

Awards & highlights

V-SPINE Trial Summary

This trial is comparing two different medications, norepinephrine and phenylephrine, to see which one works better in supporting blood pressure during spinal fusion surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects from Norepinephrine and Phenylephrine may include irregular heartbeat, headache, nervousness, restlessness, and possibly skin changes due to reduced blood flow.

V-SPINE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

V-SPINE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from admission to discharge (up to 100 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from admission to discharge (up to 100 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from admission to discharge (up to 100 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Vasopressor requirement

Secondary outcome measures

30-day readmission

Intraoperative transfusion requirement

Length of ICU stay

+5 more

V-SPINE Trial Design

2Treatment groups

Active Control

Group I: NorepinephrineActive Control1 Intervention

Patients receiving norepinephrine for intraoperative hypotension

Group II: PhenylephrineActive Control1 Intervention

Patients receiving phenylephrine for intraoperative hypotension

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,615 Total Patients Enrolled

Siddharth Dave, MDPrincipal InvestigatorUT Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process still open for individuals interested in participating in this trial?

"Indeed, clinicaltrials.gov indicates that this study is actively seeking eligible participants. The initial posting of the trial occurred on November 21, 2023 and the most recent update was made on January 11, 2024."

Answered by AI

What is the upper threshold for the number of individuals enrolled in this medical study?

"Indeed, the details provided on clinicaltrials.gov indicate that this trial is currently seeking participants. The initial posting of the trial was made on November 21st, 2023 and it was last updated on January 11th, 2024. To complete the study, a total of 120 patients will be enrolled from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vasopressor Outcomes in Spine Surgery

Siddharth Dave 2023. "Vasopressor Outcomes in Spine Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06053398.