The Effects of Perioperative Nutritional Optimization on Blood Markers

Intervertebral Disc Disorders With Radiculopathy, Lumbar Region Clinical Trial

Official title:

The Effects of Perioperative Nutritional Optimization on Blood Markers of Nutritional Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464161
• Other study ID #: 20-00748
• Status: Completed
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: June 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if taking an oral nutrition supplement (Ensure Nutrition Shake) before and after lumbar spine surgery affects blood tests related the nutritional status of patients. Patients with poor nutritional statuses who undergo elective lumbar spine surgery are at increased risk for complications and longer hospitalizations.

Description:

The study will examine whether a simple and cost-effective perioperative nutritional program will affect blood markers of nutritional status (albumin, pre-albumin, transferrin, electrolytes). All patients 55 years and older who are undergoing lumbar spine surgery at our institution by a single surgeon and meet all inclusion criteria will be added to this study. Patients will be randomized into one of two arms; the interventional group will be provide with daily Ensure protein drinks for two weeks pre-operatively and four weeks post-operatively, while the control group will be instructed to continue their current diet plans. Four weeks post-operatively, blood markers (serum albumin, pre-albumin, transferrin, electrolyes) will be obtained to assess objective differences in nutritional status.

N/A

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 1, 2021
• Est. primary completion date: April 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients aged 55 years and older undergoing primary lumbar spine surgery for the treatment of radiculopathy and other lumbar pathologies

• Patients have the willingness and ability to participate in a study procedure

Exclusion Criteria:

• Patients who are younger than 55 years old

• Patients undergoing revision surgery

• Patients undergoing surgery due to trauma/fractures

• Patients with lactose intolerance

Related Conditions & MeSH terms

• Intervertebral Disc Disorders With Radiculopathy, Lumbar Region
• Radiculopathy

Intervention

Dietary Supplement:
• Ensure
Ensure protein is a complete nutritional drink with 10g, 240 calories, and 27 vitamins and minerals. It is often used as a nutritional supplementation in many hospitals.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in blood markers in patients	Nutritional status of patients undergoing lumbar surgery will be measured by their blood markers. T-tests with a p value of 0.05 will be used for these tests. Chi square and t-tests will be used.	Baseline, 4 weeks post-operative visit