Preoperative Oral Hydration in the Ambulatory Arthroplasty Population

Length of Stay Clinical Trial

Official title:

Preoperative Oral Hydration in the Ambulatory Arthroplasty Population :A Single-Blinded Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05520593
• Other study ID #: 2020-2597
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2022
• Est. completion date: January 24, 2024

Study information

• Verified date: June 2023
• Source: Hospital for Special Surgery, New York
• Contact: Jose Rodriguez, MD
• Phone: 212-552-5829
• Email: rodriguezjose[@]hss.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate if the consumption of a complex carbohydrate drink preoperatively, decreases the length of stay and causes for failure to launch in patients undergoing ambulatory total joint arthroplasty.

Description:

The way total joint arthroplasty is practiced continues to evolve as CMS removed total hip arthroplasty (THA) from the inpatient-only list and added total knee arthroplasty (TKA) to the ASC Covered Surgical Procedures List (CPL) in 2020. Thus, surgeons must find subtle interventions that improve patient outcomes while minimizing the risk of adverse reactions. Current literature has not assessed the influence of preoperative hydration, using a complex carbohydrate drink, on the same-day discharge rate and causes for failure to launch. Considering variabilities in perioperative fluid management leading to postoperative nausea, vomiting, and dizziness, the investigators seek to reduce the incidence of these events by optimizing patients using a preoperative oral hydration protocol, reducing the length of stay, and improving same-day discharge rates.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: January 24, 2024
• Est. primary completion date: January 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Candidates for ambulatory total knee arthroplasty
• Candidates for ambulatory total hip arthroplasty
• Candidates for ambulatory revision knee arthroplasty (liner exchange only)
• Candidates for ambulatory revision hip arthroplasty (liner exchange only)
• Case scheduled before noon (12 pm)
• Patient agrees to same-day discharge and has a responsible adult to spend the night on the day of discharge

Exclusion Criteria:

• BMI less than 18.5 or greater than 37.0
• Patients with diabetes, chronic kidney disease, clotting disorders, or neurological conditions preventing control of the affected limb.
• Pregnant women
• Patients scheduled as ambulatory due to insurance mandates
• Patients with a history of active ischemia, significant valvular disease, significant arrhythmias, obstructive sleep apnea as per Hospital for Special Surgery guidelines, chronic opioid dependence (chronic daily opioid use for six or more months), and glomerular filtration rate < 60ml/min.

Related Conditions & MeSH terms

• Length of Stay

Intervention

Dietary Supplement:
• Complex Carbohydrate Drink
Patients will drink a complex carbohydrate drink 3 hours before surgery. Drink to be given at the preoperative holding area.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay in hours	Length of hospital stay in hours, assess by medical record.	From admission to discharge, up to 1 week
Secondary	Same day discharge rate	Percentage of patients discharged successfully the day of surgery.	Through study completion, an average of 3 months.
Secondary	Number of physical therapy sessions attempted	Number of physical therapy sessions attempted, assess by medical record.	From admission to discharge, up to 1 week.
Secondary	Total distance walked	Total distance walked during physical therapy attempts, assess by medical record.	From admission to discharge, up to 1 week.
Secondary	Number of stairs climbed	Number of stairs climbed during physical therapy attempts, assess by medical record.	From admission to discharge, up to 1 week.
Secondary	Orthostatic hypotension episodes	Orthostatic hypotension episodes during physical therapy attempts, assess by medical record.	During physical therapy attempts, from admission to discharge.
Secondary	HOOS JR Score	This is a 6-item questionnaire that assesses patient-reported hip pain and function. Score ranges from 0-100, with 100 representing the best possible score.	The morning of surgery and at the first post-operative visit, up to 4 months post-op.
Secondary	KOOS JR Score	This is a 6-item questionnaire that assesses patient reported knee pain and function. Score ranges from -100, with 100 representing the best score possible.	The morning of surgery and at the first post-operative visit, up to 4 months post-op.
Secondary	VR-12 Score	The VR-12 is a 12-item self-reported questionnaire that assesses the patient physical and mental quality of life.	The morning of surgery and at the first post-operative visit, up to 4 months post-op.
Secondary	Urine osmolality	Urine osmolality taken preoperatively, assess by medical record.	Measured preoperatively the morning of surgery.
Secondary	Urine specific gravity	Urine specific gravity preoperatively, assess by medical record.	Measured preoperatively the morning of surgery.
Secondary	In-house costs	In-house costs taking into account cost of complex carbohydrate drink vs previously published costs savings per night of stay.	From admission to discharge, up to 1 week.