Oral Fluid vs IV Fluid After Primary TKA

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288815
• Other study ID #: TUH oral fluid TKA
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Thammasat University Hospital
• Contact: Yot Tanariyakul, M.D.
• Phone: 663930257
• Email: y.tanariyakul[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee
• Total Knee Arthroplasty

Intervention

Dietary Supplement:
• Oral fluid
Postoperation Off IV fluid immediately postoperative Allow patients drink oral fluid as protocol for 24hr
• IV fluid
Postoperation IV fluid replacement as protocol for 24hr Allow patients drink oral fluid as usual

Locations

Country	Name	City	State
Thailand	Thammasat University	Khlong Luang	Pathum Thani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

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