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Completed

NCT Number: NCT03719378

Traditional vs Oral Fluid Management in Total Knee Arthroplasty

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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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado Joint Replacement

Denver, Colorado, 80210, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients between the ages of 18-75 years old undergoing a primary total knee arthroplasty for a diagnosis of degenerative osteoarthritis who do not meet the exclusion criteria listed below

Exclusion criteria

  • Volume-dependent cardiac conditions:
  • Aortic stenosis
  • Pulmonary valve stenosis
  • Subaortic stenosis
  • Severe Aortic Insufficiency
  • Chronic systolic heart failure
  • Eisenmeinger Syndrome
  • Severe pulmonary HTN
  • Chronic or paroxysmal dysrhythmias
  • Pre-operative electrolyte abnormalities
  • Abnormalities of the HPA (hypothalamic-pituitary axis)
  • Stage 3 Chronic Kidney Disease (or worse)
  • Patients taking angiotensin receptor blockers (ARB)
  • Patients with uncontrolled diabetes mellitus (patient with A1C of 7+ or on insulin)
  • Patients whose BMI is > 35 38 or < 19
  • Current use of long acting narcotic medication or 3 or more months of daily short acting narcotic medication
  • Patients at risk for electrolyte abnormalities, dehydration or intra-operative hypotension. (patients taking angiotensin receptor blockers, ACE inhibitors (48 hours prior to surgery) and Diuretics)
  • Patients with severe, untreated or uncontrolled GERD.
  • Patients that cannot receive spinal anesthesia (e.g. patient with back fusions)
  • Pre-Operative Anemia

Treatment and study plan

Pre Operative Oral Fluids

Other

Patients will be self hydrating prior to their total knee replacement.

Primary outcomes

  1. Body Weight

    Time frame: Change is patients weight from baseline at pre op to two weeks post op.

    Patient Weight will be monitored

Secondary outcomes

  1. Knee Range of Motion

    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)

  2. Leg Anthropometric (Girth) Measurements

    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.

  3. Number of Participants With Requiring Transfusions

    Time frame: intra operative, Post Op Day #1 or #2

    Post Operative/Intra Operative Transfusions

  4. Number of Participants With Off Wound Complications Post Operative

    Time frame: Up to 6 weeks Post OP

    incidence of wound infection and wound drainage will be assessed and recorded

  5. Number of Participants With Thromboembolic Disease

    Time frame: Post Opeartive until the 6 week follow up appointment

    The incidence of thromboembolic events will be recorded.

  6. Quadriceps Strength Measure With a Handheld Dynamometer

    Time frame: Post Op day 1, 2 Week and 6 Week Post OP

    The strength testing will be calculated using a handheld dynamometer

  7. Time up and GO

    Time frame: preoperative appointment and once again at their 2 and 6 weeks postoperatively

    timed up and go (TUG)

  8. 30 Second STS Test

    Time frame: preoperative appointment and once again at their 2 and 6 weeks postoperatively

    30 second sit-to-stand tests

  9. Length of the Hospitalization

    Time frame: Daily up to 2 days while hospitalized

    Length of time the patient is Hospitalized after their total knee replacement.

  10. Number of Patients Re-admitted Post TKA

    Time frame: up to 6 weeks post op

    Number of patients re-admitted post TKA

  11. Postoperative Pain Assessment Using Visual Analog Scale

    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.

  12. PONV (Post-operative Nausea and Vomiting)

    Time frame: Daily up to 2 days while hospitalized

    patients will be asked about Nausea: None, Mild, Moderate or Severe

  13. Veterans Rand -12

    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

  14. Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)

    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.

  15. Patient Reported Outcomes - Knee Society Score(KSS)

    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.

  16. Total IV Fluids Received

    Time frame: Duration of IV intervention, up to 2 days

    Total amount of IV fluids that the patients received while in the hospital

  17. Bioimpedence

    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.

Other outcomes

  1. Number of Participants With Adverse Events

    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

  2. Blood Pressure

    Time frame: Daily up to 2 days while hospitalized

    Blood Pressure (Diastolic/ Systolic)

  3. Total Number of Patients That Received Any Pressor Drugs

    Time frame: Up to Day 1 Post op

    total amount of any pressor drugs given intraoperatively (e.g. Ephedrine and Phenylephrine)

Sponsors and collaborators

Lead sponsor

Colorado Joint Replacement

Other

Registry information

Official study title

Traditional Intravenous Versus Oral Fluid Management in Total Knee Arthroplasty

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 25, 2018
Registry last updated
Mar 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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