Same-day DischargeNCT05520593
Preoperative Oral Hydration in the Ambulatory Arthroplasty Population
A study testing Complex Carbohydrate Drink in people with Same-day Discharge and Length of Stay, run by Hospital for Special Surgery, New York at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Same-day Discharge, Length of Stay
- What is being tested?
- Complex Carbohydrate Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Ricardo Torres, BS, 2122603763, torresr@hss.edu
Samuel Rodriguez, MD
About this study
Official title: Preoperative Oral Hydration in the Ambulatory Arthroplasty Population :A Single-Blinded Randomized Control Trial
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.
Read the 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.
- Conditions
- Same-day Discharge, Length of Stay
- Being tested
- Complex Carbohydrate Drink
- Keywords
- Carbohydrate Drink, Perioperative Fluids, Same-day Discharge, Total Joint Arthroplasty, Nausea, Vomiting, Same-day total hip arthroplasty, Same-day total knee arthroplasty
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Carbohydrate DrinkDietary supplement
Patients will drink a complex carbohydrate drink 3 hours before surgery. Drink to be given at the preoperative holding area.
| Study group | Role | What they receive |
|---|---|---|
| Complex Carbohydrate Drink Group | Experimental | 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. Receives: Dietary Supplement: Complex Carbohydrate Drink |
| No-Complex Carbohydrate Drink Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay in hours
Length of hospital stay in hours, assess by medical record.
Measured: From admission to discharge, up to 1 week
Secondary outcomes (11)
Same day discharge rate
Percentage of patients discharged successfully the day of surgery.
Measured: Through study completion, an average of 3 months.
Number of physical therapy sessions attempted
Number of physical therapy sessions attempted, assess by medical record.
Measured: From admission to discharge, up to 1 week.
Total distance walked
Total distance walked during physical therapy attempts, assess by medical record.
Measured: From admission to discharge, up to 1 week.
Number of stairs climbed
Number of stairs climbed during physical therapy attempts, assess by medical record.
Measured: From admission to discharge, up to 1 week.
Orthostatic hypotension episodes
Orthostatic hypotension episodes during physical therapy attempts, assess by medical record.
Measured: During physical therapy attempts, from admission to discharge.
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.
Measured: The morning of surgery and at the first post-operative visit, up to 4 months post-op.
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.
Measured: The morning of surgery and at the first post-operative visit, up to 4 months post-op.
VR-12 Score
The VR-12 is a 12-item self-reported questionnaire that assesses the patient physical and mental quality of life.
Measured: The morning of surgery and at the first post-operative visit, up to 4 months post-op.
Urine osmolality
Urine osmolality taken preoperatively, assess by medical record.
Measured: Measured preoperatively the morning of surgery.
Urine specific gravity
Urine specific gravity preoperatively, assess by medical record.
Measured: Measured preoperatively the morning of surgery.
In-house costs
In-house costs taking into account cost of complex carbohydrate drink vs previously published costs savings per night of stay.
Measured: From admission to discharge, up to 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start7 Nov 2022
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Same-day DischargeStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Rodriguez, Hospital for Special Surgery, New York
- Investigators
- Jose A Rodriguez, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520593
- Sponsor's protocol ID
- 2020-2597
- Status last verified
- Feb 2026
- First submitted
- 24 Aug 2022
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Oral Hydration in the Ambulatory Arthroplasty Population :A Single-Blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05520593
- Acronym / sponsor ID
- 2020-2597
- Conditions
- Same-day Discharge, Length of Stay
- Keywords
- Carbohydrate Drink, Perioperative Fluids, Same-day Discharge, Total Joint Arthroplasty, Nausea, Vomiting, Same-day total hip arthroplasty, Same-day total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex Carbohydrate Drink Group | Experimental | Dietary Supplement: Complex Carbohydrate DrinkThe 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. |
| No-Complex Carbohydrate Drink Group | No 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex Carbohydrate DrinkPatients will drink a complex carbohydrate drink 3 hours before surgery. Drink to be given at the preoperative holding area. | Dietary supplement | Complex Carbohydrate Drink Group |
Primary outcome
Length of hospital stay in hours
Time frame: From admission to discharge, up to 1 week
Length of hospital stay in hours, assess by medical record.
11 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jose A Rodriguez, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex Carbohydrate Drink in people with Same-day Discharge and Length of Stay, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Rodriguez, MD (212-552-5829, rodriguezjose@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay in hours (time frame: From admission to discharge, up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.