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The Effects of Perioperative Nutritional Optimization on Blood Markers

Primary Purpose

Intervertebral Disc Disorders With Radiculopathy, Lumbar Region

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ensure
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intervertebral Disc Disorders With Radiculopathy, Lumbar Region

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm 1

Arm 2

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 7, 2020
Last Updated
June 16, 2022
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04464161
Brief Title
The Effects of Perioperative Nutritional Optimization on Blood Markers
Official Title
The Effects of Perioperative Nutritional Optimization on Blood Markers of Nutritional Status
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
April 19, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Disorders With Radiculopathy, Lumbar Region

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm 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.
Arm Title
Arm 2
Arm Type
No Intervention
Arm Description
The control group will be instructed to continue to their regular diets.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ensure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in blood markers in patients
Description
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.
Time Frame
Baseline, 4 weeks post-operative visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Passias, MD
Organizational Affiliation
NYU Langone Hleath
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Hesham.saleh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

The Effects of Perioperative Nutritional Optimization on Blood Markers

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