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Recruiting NCT05520593

Preoperative Oral Hydration in the Ambulatory Arthroplasty Population

No phase Interventional Same-day Discharge Length of Stay

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Complex Carbohydrate Drink.
Who it may be relevant to
Registry conditions: Same-day Discharge, Length of Stay. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed 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.

Interventions

  • 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.

Primary outcome measures

  • Length of hospital stay in hours [Time frame: From admission to discharge, up to 1 week]
Secondary outcome measures (11)
  • Same day discharge rate [Time frame: Through study completion, an average of 3 months.]
  • Number of physical therapy sessions attempted [Time frame: From admission to discharge, up to 1 week.]
  • Total distance walked [Time frame: From admission to discharge, up to 1 week.]
  • Number of stairs climbed [Time frame: From admission to discharge, up to 1 week.]
  • Orthostatic hypotension episodes [Time frame: During physical therapy attempts, from admission to discharge.]
  • HOOS JR Score [Time frame: The morning of surgery and at the first post-operative visit, up to 4 months post-op.]
  • KOOS JR Score [Time frame: The morning of surgery and at the first post-operative visit, up to 4 months post-op.]
  • VR-12 Score [Time frame: The morning of surgery and at the first post-operative visit, up to 4 months post-op.]
  • Urine osmolality [Time frame: Measured preoperatively the morning of surgery.]
  • Urine specific gravity [Time frame: Measured preoperatively the morning of surgery.]
  • In-house costs [Time frame: From admission to discharge, up to 1 week.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Hospital for Special Surgery — New York

Identifiers

NCT: NCT05520593 · 2020-2597

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗