The Effects of Perioperative Nutritional Optimization on Blood Markers

NYU Langone Health

Status: Completed

Conditions: Intervertebral Disc Disorders With Radiculopathy, Lumbar Region

Treatments: Dietary Supplement: Ensure

Study type: Interventional

Funder types: Other

Identifiers

NCT04464161

20-00748

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 patients

Sex: All

Ages: 55 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Arm 1

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Ensure

Arm 2

No Intervention group

Description:

The control group will be instructed to continue to their regular diets.