The Effects of Perioperative Nutritional Optimization on Blood Markers

NCT04464161 | Completed DMC

• 1 other identifier: 20-00748
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Intervertebral Disc Disorders With Radiculopathy, Lumbar Region

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

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.

Dietary Supplement: Ensure

Arm 2

NO INTERVENTION

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

Interventions

Ensure DIETARY_SUPPLEMENT

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.

Arm 1

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who are younger than 55 years old
• Patients undergoing revision surgery
• Patients undergoing surgery due to trauma/fractures
• Patients with lactose intolerance

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Study Officials

• Peter Passias, MD

  NYU Langone Hleath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 9, 2020
• Study Start: July 20, 2020
• Primary Completion: April 19, 2021
• Study Completion: August 1, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)