The Effects of Perioperative Nutritional Optimization on Blood Markers

Not Applicable

Completed

• Conditions: Intervertebral Disc Disorders With Radiculopathy, Lumbar Region
• Interventions: Dietary Supplement: Ensure

• Registration Number: NCT04464161
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-09
• Study Start: 2020-07-20
• Primary Completion: 2021-04-19
• Study Completion: 2021-08-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Ensure	The treatment arm will receive 6 week supply of daily Ensure protein drinks, while the control arm will be instructed to continue their current diet. This includes 2 weeks pre-operatively and 4 weeks post-operatively.

Primary Outcome Measures

Name	Time	Method
Difference in blood markers in patients	Baseline, 4 weeks post-operative visit	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States