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Complex Carbohydrate Drink
Preoperative Hydration Drink for Joint Surgery Recovery
N/A
Recruiting
Led By Jose A Rodriguez, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured preoperatively the morning of surgery.
Awards & highlights
Study Summary
This trial looks at whether drinking a special drink before surgery can reduce hospital stays and help people recover faster after joint surgery.
Who is the study for?
This trial is for people getting same-day knee or hip arthroplasty (liner exchange only) and scheduled before noon. They must agree to leave the hospital the same day with an adult to stay overnight. Not for those underweight/overweight, forced into ambulatory surgery by insurance, pregnant, diabetic, with kidney disease/clotting/neurological issues affecting limb control, heart problems, sleep apnea, opioid dependence or poor kidney function.Check my eligibility
What is being tested?
The study tests if drinking a complex carbohydrate drink before surgery can help patients go home sooner after ambulatory total joint arthroplasty without complications that would prevent them from leaving ('failure to launch').See study design
What are the potential side effects?
Since this trial involves a nutritional drink rather than medication, side effects may be minimal but could include digestive discomfort or allergic reactions in rare cases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured preoperatively the morning of surgery.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured preoperatively the morning of surgery.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Length of hospital stay in hours
Secondary outcome measures
HOOS JR Score
In-house costs
KOOS JR Score
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Complex Carbohydrate Drink GroupExperimental Treatment1 Intervention
The patients will drink a 400ml drink that contains 50g of complex carbohydrates, 3 hours prior to the surgery. The drink will be given once at the preoperative holding area. Patients are not allowed to eat solid foods after 12am the morning of surgery and can only drink clear fluids up to 3 hours prior to the surgery.
Group II: No-Complex Carbohydrate Drink GroupActive Control1 Intervention
These patients will follow normal institutional preoperative fluid management guidelines, this consist of no solid foods after 12am the morning of surgery. Patients are allowed to drink clear liquids (water, clear fruit juices, coffee) from 12am the morning of surgery up to 3 hours prior to the surgery.
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Who is running the clinical trial?
Hospital for Special Surgery, New YorkLead Sponsor
245 Previous Clinical Trials
59,198 Total Patients Enrolled
Jose A Rodriguez, MDPrincipal InvestigatorHospital for Special Surgery, New York
2 Previous Clinical Trials
139 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is either too low or too high.You are eligible for outpatient knee replacement surgery.You are a candidate for a hip replacement surgery that will allow you to go home the same day.You are currently pregnant.You have diabetes, chronic kidney disease, or a condition that affects blood clotting or nerve function in the limb being studied.You have a history of heart disease, sleep apnea, prolonged opioid use, or decreased kidney function.
Research Study Groups:
This trial has the following groups:- Group 1: No-Complex Carbohydrate Drink Group
- Group 2: Complex Carbohydrate Drink 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.
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