Oral Fluid vs IV Fluid After Primary TKA
Comparison Efficacy of Oral Fluid Versus Intravenous Fluid Replacement in Postoperative Primary Total Knee Arthroplasty : A Randomized Controlled Trial.
1 other identifier
interventional
130
1 country
1
Brief 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2024
CompletedFirst Submitted
Initial submission to the registry
February 25, 2024
CompletedFirst Posted
Study publicly available on registry
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedMarch 4, 2024
March 1, 2024
11 months
February 25, 2024
March 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Time to stand and walk
Stand and walk with walker
Postoperative day 1
Secondary Outcomes (8)
Time up and go
24 and 48 hours
Incidence of oliguria
Postoperative day 1,2
Incidence of nausea/vomiting
Postoperative day 1,2
Urine specific gravity
Postoperative day 1
the levels of certain electrolytes
Postoperative day 1,2
- +3 more secondary outcomes
Study Arms (2)
Oral fluid
EXPERIMENTAL* 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)
IV fluid
ACTIVE COMPARATOR* 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)
Interventions
Postoperation * Off IV fluid immediately postoperative * Allow patients drink oral fluid as protocol for 24hr
Postoperation * IV fluid replacement as protocol for 24hr * Allow patients drink oral fluid as usual
Eligibility Criteria
You may qualify if:
- Age 40-85 years old
- ASA I, II
- Primary osteoarthritis
You may not qualify if:
- Diuretics use
- Morbid obesity
- Previous knee surgery
- Cannot undergo spinal anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thammasat University
Khlong Luang, Changwat Pathum Thani, 12120, Thailand
Related 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.
PMID: 32037213BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator
Study Record Dates
First Submitted
February 25, 2024
First Posted
March 1, 2024
Study Start
January 10, 2024
Primary Completion
December 1, 2024
Study Completion
June 1, 2025
Last Updated
March 4, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share