Vasopressor Outcomes in Spine Surgery

Hypotension Clinical Trial

— V-SPINE  

Official title:

Vasopressor Outcomes in Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06053398
• Other study ID #: STU-2023-0326
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 21, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Siddharth Dave, MD
• Phone: 6469321770
• Email: siddharth.dave[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

There is limited evidence on the difference in postoperative outcomes between the choices of vasopressors used to treat intraoperative hypotension (IOH) in patients undergoing non-cardiac surgery under general anesthesia. A recent pilot feasibility trial comparing norepinephrine and phenylephrine for first-line intravenous infusion of vasopressor during general anesthesia and major non-cardiac surgery was unable to show any difference in postoperative outcomes. Although the study demonstrated safety and feasibility, it was not powered to detect differences in postoperative outcomes. The impact of vasopressors on postoperative outcomes in patients undergoing complex spinal surgery in the prone position is even scarcer. While it has been demonstrated that the use of intra-operative vasopressor infusion is safe and well tolerated, without any adverse renal outcomes, it is unclear if the choice of vasopressor makes any difference. While animal studies have shown that norepinephrine may provide greater spinal cord protection than phenylephrine, clinical studies in humans are lacking. We aim to fill this gap in knowledge by carrying out a prospective, randomized control trial to evaluate differential outcomes related to the choice of norepinephrine versus phenylephrine as the preferential vasopressor in patients undergoing elective spinal fusion surgery in the prone position.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Age < 18 years

• Emergency surgery

• Outpatient surgery

• Pregnancy

• End-stage renal disease requiring dialysis

• Diagnosed myocardial ischemia and/or cardiac revascularization within the past month

Related Conditions & MeSH terms

• Hypotension

Intervention

Drug:
• Phenylephrine
Intraoperative phenylephrine infusion Phenylephrine infusion to be titrated as needed to target a mean arterial pressure (MAP) > 65 mm Hg.
• Norepinephrine
Intraoperative norepinephrine infusion Norepinephrine infusion to be titrated as needed to target a MAP > 65 mm Hg.

Locations

Country	Name	City	State
United States	Clements University Hospital at Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vasopressor requirement	Total intraoperative vasopressor requirement	During inpatient admission
Secondary	Postoperative acute kidney injury	Kidney Disease Improving Global Outcomes (KDIGO) criteria; Acute Kidney Injury (AKI) is defined as any of the following: Increase in serum creatinine (sCr) =0.3 mg/dL (=26.5 µmol/L) within 48 hours; or; Increase in sCr =1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or; Urine volume <0.5 mL/kg/h for 6 hours	During inpatient admission
Secondary	Intraoperative transfusion requirement		During inpatient admission
Secondary	Postoperative vasopressor requirement		During inpatient admission
Secondary	Length of ICU stay		During inpatient admission
Secondary	Length of hospital stay		From admission to discharge (up to 100 weeks)
Secondary	30-day readmission		30-days post-discharge
Secondary	Postoperative Myocardial Injury	Troponin elevation (ng/L)	During inpatient admission
Secondary	Postoperative Lactate Elevation	Lactate (mmol/L)	During inpatient admission