Colorado Joint Replacement
Denver, Colorado, 80210, United States
NCT Number: NCT03719378
Purpose: Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. This study will investigate the effects of two regimens of intraoperative fluid management ("traditional" vs. "oral") with physiologic and patient function as primary outcome measures after surgery.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Denver, Colorado, 80210, United States
Evidence-based guidelines on optimal perioperative fluid management have not been established in patients undergoing orthopaedic surgery. Typical intraoperative and post-operative fluid management has been arbitrary without evidence based guidelines established following total joint replacement. The investigators have observed many patients post-operatively with side effects such as fluid overload leading to medical complications requiring either prolonged hospitalization or readmission. Additionally, this overload may lead to wound healing complications secondary to fluid shifts which may be devastating in this patient population. Recent randomized trials in major abdominal surgery suggest that large amounts of IV fluid may increase morbidity and hospital stay. Additionally, this increase fluid may be detrimental in patients with anastomosis leading to failure and/or complications in this patient population. The investigators have defined to specific groups of interest to study in this patient population with regards to fluid management. The first group is the "traditional" IV fluid group where the anesthesiologist gives an unspecific amount of fluid intraoperatively and post-operatively the patient gets a set amount of fluid based on "protocol" on the orthopaedic floor (i.e. 75 cc/hour until good oral intake). This is the protocol utilized by most orthopaedic practices throughout the United States. The second group is defined as patients who are given a specific protocol preoperatively to optimize hydration, followed by limited fluids intraoperatively based on physiologic parameters. This study will investigate the effects of two regimens of intraoperative fluid management ("traditional" vs. "oral") with
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be self hydrating prior to their total knee replacement.
Time frame: Change is patients weight from baseline at pre op to two weeks post op.
Patient Weight will be monitored
Time frame: Post Op Day 1, 2 Weeks and 6 Weeks Post Op
Measurements will be done with a standard goniometer (Measurements below are shown as the difference from their pre operative base line measurement to the time points below)
Time frame: Post op Day 1, 2 weeks and 6 weeks Post Op
measurements will be performed at 5 & 10 cm suprapatellar, midpatella, and 10 cm infrapatellar with the use of a standard tape measure. measurements below show the difference from their pre operative base line measurement to the timepoints below.
Time frame: intra operative, Post Op Day #1 or #2
Post Operative/Intra Operative Transfusions
Time frame: Up to 6 weeks Post OP
incidence of wound infection and wound drainage will be assessed and recorded
Time frame: Post Opeartive until the 6 week follow up appointment
The incidence of thromboembolic events will be recorded.
Time frame: Post Op day 1, 2 Week and 6 Week Post OP
The strength testing will be calculated using a handheld dynamometer
Time frame: preoperative appointment and once again at their 2 and 6 weeks postoperatively
timed up and go (TUG)
Time frame: preoperative appointment and once again at their 2 and 6 weeks postoperatively
30 second sit-to-stand tests
Time frame: Daily up to 2 days while hospitalized
Length of time the patient is Hospitalized after their total knee replacement.
Time frame: up to 6 weeks post op
Number of patients re-admitted post TKA
Time frame: Every 4 hours, averaged daily, reported at Post op day 1 and 2 (while in the hospital), weeks 1, 2, 3, and 4 (3 times a day)
Pain will be assessed using a pain Visual Analog scale(VAS), the scale is from 1 to 10, the higher the score the worse the pain.
Time frame: Daily up to 2 days while hospitalized
patients will be asked about Nausea: None, Mild, Moderate or Severe
Time frame: 2 week and 6 week follow up appointments
Patient Reported Outcomes- Veterans Rand(VR-12), there is an algorithm to calculate this score, not a specific range. The higher the number the more positive the output. The score has two components a mental score (MCS) and Physical Score (PCS). Higher values represent a better outcome.
MCS Scale 35.089613 to 46.341715 PCS Scale 14.957554 to 63.235672
Time frame: pre-operatively as well as at their 2 week and 6 week follow up appointments
Knee injury and Osteoarthritis Outcome Score (KOOS), the scale is 0 to 100, 100 being the best score possible.
Time frame: pre-operatively as well as at their 2 week and 6 week follow up appointments
Knee Society Score(KSS), the total scores range from 0 - 200, 200 being the best.
Time frame: Duration of IV intervention, up to 2 days
Total amount of IV fluids that the patients received while in the hospital
Time frame: pre-op visit, Post Op Day #1 as well as their 2 week and 6 week visit
body composition before and after surgery to measure swelling. Lower numbers represent more swelling.
Time frame: While in hospital until the 6 week follow up appointment
episodes such as symptomatic hypotension (light-headedness, syncope), emesis, the need the IV fluid boluses, and other hospital and post-discharge events will be recorded
Time frame: Daily up to 2 days while hospitalized
Blood Pressure (Diastolic/ Systolic)
Time frame: Up to Day 1 Post op
total amount of any pressor drugs given intraoperatively (e.g. Ephedrine and Phenylephrine)
Colorado Joint Replacement
Other
Traditional Intravenous Versus Oral Fluid Management in Total Knee Arthroplasty
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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