Trials / Completed
CompletedNCT04464161
The Effects of Perioperative Nutritional Optimization on Blood Markers
The Effects of Perioperative Nutritional Optimization on Blood Markers of Nutritional Status
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 55 Years – 100 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2020-07-20
- Primary completion
- 2021-04-19
- Completion
- 2021-08-01
- First posted
- 2020-07-09
- Last updated
- 2022-06-22
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04464161. Inclusion in this directory is not an endorsement.