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RecruitingNCT06288815Updated Mar 4, 2024

Oral Fluid vs IV Fluid After Primary TKA

An interventional study of Oral fluid and IV fluid in Osteoarthritis, Knee, Total Knee Arthroplasty and Oral Fluid Replacement, sponsored by Thammasat University Hospital. Recruiting at 1 site in Thailand. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-03-04.

Sponsored by Thammasat University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study summary

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?

02

Conditions studied

  • Osteoarthritis, Knee
  • Total Knee Arthroplasty
  • Oral Fluid Replacement
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's planned enrollment of 130 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Thammasat University Hospital is the lead sponsor of 16 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Diuretics use
  • Morbid obesity
  • Previous knee surgery
  • Cannot undergo spinal anesthesia
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
130 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementOral fluid

    Postoperation * Off IV fluid immediately postoperative * Allow patients drink oral fluid as protocol for 24hr

  • Dietary supplementIV fluid

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

06

What researchers measure

Primary outcomes

  1. Time to stand and walk

    Stand and walk with walker

    Time frame: Postoperative day 1

Secondary outcomes

  1. Time up and go

    Record time since stand up and walk 3 meters, or 10 feet away, on the floor

    Time frame: 24 and 48 hours

  2. Incidence of oliguria

    Urine output \< 0.5ml/kg/hr

    Time frame: Postoperative day 1,2

  3. Incidence of nausea/vomiting

    record symptom of nausea and vomiting

    Time frame: Postoperative day 1,2

  4. Urine specific gravity

    Urine specific gravity every 4 hours

    Time frame: Postoperative day 1

  5. the levels of certain electrolytes

    Blood chemistry

    Time frame: Postoperative day 1,2

  6. the levels of creatinine

    Blood chemistry

    Time frame: Postoperative day 1,2

  7. the levels of blood urea nitrogen (BUN).

    Blood chemistry

    Time frame: Postoperative day 1,2

  8. Complications

    Pulmonary edema, heart failure, acute kidney injury

    Time frame: Until postoperative 3months

07

Study locations

1 of 1 sites recruiting
  • Thammasat University
    Khlong Luang, Pathum Thani 12120, Thailand
    • Yot Tanariyakul, M.D. · Contact · y.tanariyakul@gmail.com · 663930257
    • Nattapol Tammachote, M.D. · Principal investigator
    Recruiting
08

References and documents

Publications

  • Jennings JM, Mejia M, Williams MA, Johnson RM, Yang CC, Dennis DA. The James A. Rand Young Investigator's Award: Traditional Intravenous Fluid vs. Oral Fluid Administration in Primary Total Knee Arthroplasty: A Randomized Trial. J Arthroplasty. 2020 Jun;35(6S):S3-S9. doi: 10.1016/j.arth.2020.01.029. Epub 2020 Jan 22. PubMed 32037213 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06288815
Lead sponsor
Thammasat University Hospital
Responsible party
Yot Tanariyakul (Principle investigator, Thammasat University Hospital) — Principal investigator
First posted
Mar 1, 2024
Start date
Jan 10, 2024
Primary completion
Dec 2024 (estimated)
Completion
Jun 2025 (estimated)
Last update
Mar 4, 2024

Study contacts

Yot Tanariyakul, M.D.
Contact
y.tanariyakul@gmail.com
663930257

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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