Preoperative Oral Hydration in the Ambulatory Arthroplasty Population

April 8, 2026 updated by: Jose Rodriguez, Hospital for Special Surgery, New York

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
312

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Ricardo Torres-Ramirez, BS
  • Phone Number: 212-260-3763
  • Email: torresr@hss.edu

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Sub-Investigator:
          • Samuel Rodriguez, MD
        • Sub-Investigator:
          • Alejandro Gonzalez Della Valle, MD
        • Sub-Investigator:
          • Michael Ast, MD
        • Sub-Investigator:
          • Stravos Memtsoudis, MD
        • Sub-Investigator:
          • Ricardo Torres, BS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Complex Carbohydrate Drink Group
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.
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.
No Intervention: No-Complex Carbohydrate Drink Group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From admission to discharge, up to 1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Same day discharge rate
Time Frame: Through study completion, an average of 3 months.
Percentage of patients discharged successfully the day of surgery.
Through study completion, an average of 3 months.
Number of physical therapy sessions attempted
Time Frame: From admission to discharge, up to 1 week.
Number of physical therapy sessions attempted, assess by medical record.
From admission to discharge, up to 1 week.
Total distance walked
Time Frame: From admission to discharge, up to 1 week.
Total distance walked during physical therapy attempts, assess by medical record.
From admission to discharge, up to 1 week.
Number of stairs climbed
Time Frame: From admission to discharge, up to 1 week.
Number of stairs climbed during physical therapy attempts, assess by medical record.
From admission to discharge, up to 1 week.
Orthostatic hypotension episodes
Time Frame: During physical therapy attempts, from admission to discharge.
Orthostatic hypotension episodes during physical therapy attempts, assess by medical record.
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.
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.
KOOS JR Score
Time Frame: The morning of surgery and at the first post-operative visit, up to 4 months post-op.
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.
VR-12 Score
Time Frame: The morning of surgery and at the first post-operative visit, up to 4 months post-op.
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.
Urine osmolality
Time Frame: Measured preoperatively the morning of surgery.
Urine osmolality taken preoperatively, assess by medical record.
Measured preoperatively the morning of surgery.
Urine specific gravity
Time Frame: Measured preoperatively the morning of surgery.
Urine specific gravity preoperatively, assess by medical record.
Measured preoperatively the morning of surgery.
In-house costs
Time Frame: From admission to discharge, up to 1 week.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital for Special Surgery, New York

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jose A Rodriguez, MD, Hospital for Special Surgery, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 7, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-2597

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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