Oral Fluid vs IV Fluid After Primary TKA

March 1, 2024 updated by: Yot Tanariyakul, Thammasat University Hospital

Comparison Efficacy of Oral Fluid Versus Intravenous Fluid Replacement in Postoperative Primary Total Knee Arthroplasty : A Randomized Controlled Trial.

The goal of this study is to compared efficacy of oral fluid and intravenous fluid after primary unilateral total knee arthroplasty.

The main question it aims to answer is:

Does oral fluid replacement after primary unilateral total knee arthroplasty provide a patient recover faster than intravenous fluids replacement?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • 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 Locations

  • Thailand
    • Pathum Thani
      • Khlong Luang, Pathum Thani, Thailand, 12120
        • Recruiting
        • Thammasat University
        • Principal Investigator:
          • Nattapol Tammachote, M.D.
        • 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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 40-85 years old
  • ASA I, II
  • Primary osteoarthritis

Exclusion Criteria:

  • Diuretics use
  • Morbid obesity
  • Previous knee surgery
  • Cannot undergo spinal anesthesia

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral fluid
  • NPO (8hr for food, 2hr for water)
  • Intraoperative IV fluid at least 1 liter
  • Post operative (Off IV fluid, allow oral fluid as protocol at least 24hr)
Dietary supplement: Oral fluid

Postoperation

  • Off IV fluid immediately postoperative
  • Allow patients drink oral fluid as protocol for 24hr
Active Comparator: IV fluid
  • NPO (8hr for food, 2hr for water)
  • Intraoperative IV fluid at least 1 liter
  • Post operative (IV fluid as protocol at least 24hr, allow oral fluid as usual)
Dietary supplement: IV fluid

Postoperation

  • IV fluid replacement as protocol for 24hr
  • Allow patients drink oral fluid as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to stand and walk
Time Frame: Postoperative day 1
Stand and walk with walker
Postoperative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time up and go
Time Frame: 24 and 48 hours
Record time since stand up and walk 3 meters, or 10 feet away, on the floor
24 and 48 hours
Incidence of oliguria
Time Frame: Postoperative day 1,2
Urine output < 0.5ml/kg/hr
Postoperative day 1,2
Incidence of nausea/vomiting
Time Frame: Postoperative day 1,2
record symptom of nausea and vomiting
Postoperative day 1,2
Urine specific gravity
Time Frame: Postoperative day 1
Urine specific gravity every 4 hours
Postoperative day 1
the levels of certain electrolytes
Time Frame: Postoperative day 1,2
Blood chemistry
Postoperative day 1,2
the levels of creatinine
Time Frame: Postoperative day 1,2
Blood chemistry
Postoperative day 1,2
the levels of blood urea nitrogen (BUN).
Time Frame: Postoperative day 1,2
Blood chemistry
Postoperative day 1,2
Complications
Time Frame: Until postoperative 3months
Pulmonary edema, heart failure, acute kidney injury
Until postoperative 3months

Collaborators and Investigators

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

Sponsor

Thammasat University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 10, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 25, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUH oral fluid TKA

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

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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