Traditional vs Oral Fluid Management in Total Knee Arthroplasty

Traditional Intravenous Versus 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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Other: Pre Operative Oral Fluids

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Joint Replacement

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Traditional Fluid; NPO Clears and Food after midnight.; 2 Liters of lactated ringers administered by anesthesia intraoperatively.; Postoperatively - 2 Liters of Crystalloid while in PACU and Inpatient Room for a Total of 4 Liters of Crystalloid within 24 hours. (Patient will receive 500 milliliters while in PACU and 1500 milliliters while in their Inpatient Room, for a total of 2 Liters).; Normal diet postoperatively.
Experimental: Oral Fluid; Pre Operative Oral Fluids (Patients encouraged to drink a minimum of 60 ounces of clear liquid per day for the 3 days prior to procedure.); NPO Food/Milk: none beginning 8 hours prior to procedure time.; Pre Operative Oral Fluids (Patients are asked to drink 10 ounces of clear liquid 4 hours prior to their scheduled procedure time.); Preoperative holding area, IV is started in the patient with Lactated Ringers IV fluid at a rate of 75ml/hr. IV fluids will be stopped and hep-locked in the PACU when the patient is taking PO fluid; the total amount of IV fluids is not to exceed 500ml total.; PO fluid protocol: a minimum of 60 ounces of liquid per day for 3 days.	Other: Pre Operative Oral Fluids; Patients will be self hydrating prior to their total knee replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Patient Weight will be monitored	Change is patients weight from baseline at pre op to two weeks post op.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Range of Motion	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)	Post Op Day 1, 2 Weeks and 6 Weeks Post Op
Leg Anthropometric (Girth) Measurements	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.	Post op Day 1, 2 weeks and 6 weeks Post Op
Number of Participants With Requiring Transfusions	Post Operative/Intra Operative Transfusions	intra operative, Post Op Day #1 or #2
Number of Participants With Off Wound Complications Post Operative	incidence of wound infection and wound drainage will be assessed and recorded	Up to 6 weeks Post OP
Number of Participants With Thromboembolic Disease	The incidence of thromboembolic events will be recorded.	Post Opeartive until the 6 week follow up appointment
Quadriceps Strength Measure With a Handheld Dynamometer	The strength testing will be calculated using a handheld dynamometer	Post Op day 1, 2 Week and 6 Week Post OP
Time up and GO	timed up and go (TUG)	preoperative appointment and once again at their 2 and 6 weeks postoperatively
30 Second STS Test	30 second sit-to-stand tests	preoperative appointment and once again at their 2 and 6 weeks postoperatively
Length of the Hospitalization	Length of time the patient is Hospitalized after their total knee replacement.	Daily up to 2 days while hospitalized
Number of Patients Re-admitted Post TKA	Number of patients re-admitted post TKA	up to 6 weeks post op
Postoperative Pain Assessment Using Visual Analog Scale	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.	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)
PONV (Post-operative Nausea and Vomiting)	patients will be asked about Nausea: None, Mild, Moderate or Severe	Daily up to 2 days while hospitalized
Veterans Rand -12	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	2 week and 6 week follow up appointments
Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)	Knee injury and Osteoarthritis Outcome Score (KOOS), the scale is 0 to 100, 100 being the best score possible.	pre-operatively as well as at their 2 week and 6 week follow up appointments
Patient Reported Outcomes - Knee Society Score(KSS)	Knee Society Score(KSS), the total scores range from 0 - 200, 200 being the best.	pre-operatively as well as at their 2 week and 6 week follow up appointments
Total IV Fluids Received	Total amount of IV fluids that the patients received while in the hospital	Duration of IV intervention, up to 2 days
Bioimpedence	body composition before and after surgery to measure swelling. Lower numbers represent more swelling.	pre-op visit, Post Op Day #1 as well as their 2 week and 6 week visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	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	While in hospital until the 6 week follow up appointment
Blood Pressure	Blood Pressure (Diastolic/ Systolic)	Daily up to 2 days while hospitalized
Total Number of Patients That Received Any Pressor Drugs	total amount of any pressor drugs given intraoperatively (e.g. Ephedrine and Phenylephrine)	Up to Day 1 Post op

Collaborators and Investigators

• Sponsor: Colorado Joint Replacement

Publications and helpful links

General Publications

• Marjanovic G, Villain C, Juettner E, zur Hausen A, Hoeppner J, Hopt UT, Drognitz O, Obermaier R. Impact of different crystalloid volume regimes on intestinal anastomotic stability. Ann Surg. 2009 Feb;249(2):181-5. doi: 10.1097/SLA.0b013e31818b73dc.
• Marjanovic G, Villain C, Timme S, zur Hausen A, Hoeppner J, Makowiec F, Holzner P, Hopt UT, Obermaier R. Colloid vs. crystalloid infusions in gastrointestinal surgery and their different impact on the healing of intestinal anastomoses. Int J Colorectal Dis. 2010 Apr;25(4):491-8. doi: 10.1007/s00384-009-0854-4. Epub 2009 Nov 27.
• Kulemann B, Timme S, Seifert G, Holzner PA, Glatz T, Sick O, Chikhladze S, Bronsert P, Hoeppner J, Werner M, Hopt UT, Marjanovic G. Intraoperative crystalloid overload leads to substantial inflammatory infiltration of intestinal anastomoses-a histomorphological analysis. Surgery. 2013 Sep;154(3):596-603. doi: 10.1016/j.surg.2013.04.010. Epub 2013 Jul 19.

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2015
• Primary Completion (Actual): September 10, 2018
• Study Completion (Actual): September 10, 2018

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Fluid Management
• Other Study ID Numbers: 1060593

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No