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Carbohydrate Loading for Spine Surgery Preparation
N/A
Recruiting
Led By Chris Small, MD
Research Sponsored by Horizon Health Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time the patient is admitted to hospital until they are released postoperatively, 0-maximum hours required.
Awards & highlights
Study Summary
This trial will investigate if preoperative carb loading can improve outcomes in elderly spine surgery patients.
Who is the study for?
This trial is for elderly patients aged 65 or older who are scheduled for, or have recently had, elective spine surgery (fusion, decompression, discectomy). It's not open to those under 65, those with diabetes, anyone unable to drink the carbohydrate solution provided (Gatorade), or if they don't agree to join the study.Check my eligibility
What is being tested?
The study tests whether drinking Gatorade before spine surgery can help elderly patients by shortening their hospital stay and reducing complications. Patients will be compared based on whether they received this preoperative carbohydrate loading versus those who did not.See study design
What are the potential side effects?
Since the intervention involves consuming a common sports drink like Gatorade for carbohydrate loading, side effects may include discomfort from bloating or fullness but are generally minimal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time the patient is admitted to hospital until they are released postoperatively, 0-maximum hours required.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time the patient is admitted to hospital until they are released postoperatively, 0-maximum hours required.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of Stay (LOS) in Hospital
Secondary outcome measures
Perioperative Patient Adverse Events
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Carbohydrate GroupExperimental Treatment1 Intervention
Standard of care for dietary instructions + carbohydrate loading.
The carbohydrate (CHO) group will consist of prospectively recruited patients scheduled to undergo an elective spine surgery. These participants will also follow the preoperative nutrition standards, however, in addition, they will be instructed to consume 710ml of a simple, commercial carbohydrate sports drink on the day of their procedure up to 2 hours prior to surgery.
Group II: Control GroupActive Control1 Intervention
Standard of care for dietary instructions only.
The control group will consist of retrospectively recruited participants who have recently undergone a successful elective spine surgery, and followed the preoperative nutrition standards for their surgery, as outlined by the research institution's fasting dietary guidelines. Recruitment will include the most recent spine surgeries that meet the inclusion criteria and match prospective patient demographics.
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Who is running the clinical trial?
Horizon Health NetworkLead Sponsor
28 Previous Clinical Trials
14,364 Total Patients Enrolled
Chris Small, MDPrincipal InvestigatorCanada East Spine Centre
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I meet the age requirements for the trial.I have had or will have surgery on my neck or lower back.I meet the age requirement for the trial.I have diabetes.I am scheduled for or have recently had spine surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Carbohydrate Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for participants in this experiment?
"Affirmative. The information available on clinicaltrials.gov reveals that this medical research project is open to enrolment. It was first announced on July 13th 2022 and the most recent update occurred in March 9th 2023; 128 individuals are required across a single site for participation in this trial."
Answered by AI
What is the participant quota for this experimental trial?
"Indeed, the information on clinicaltrials.gov suggests that this medical trial is recruiting patients at present. This research project has been available since July 13th 2022 and was recently updated on March 9th 2023. The study requires 128 participants from a single centre to take part in it."
Answered by AI
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