Clinical trial NCT03719378: Traditional vs Oral Fluid Management in Total Knee Arthroplasty
Official title: Traditional Intravenous Versus Oral Fluid Management in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Keywords: Fluid Management
Lead sponsor: Colorado Joint Replacement
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Body Weight
timeFrame: Change is patients weight from baseline at pre op to two weeks post op.
Secondary outcomes:
measure: Knee Range of Motion
timeFrame: Post Op Day 1, 2 Weeks and 6 Weeks Post Op
measure: Leg Anthropometric (Girth) Measurements
timeFrame: Post op Day 1, 2 weeks and 6 weeks Post Op
measure: Number of Participants With Requiring Transfusions
timeFrame: intra operative, Post Op Day #1 or #2
measure: Number of Participants With Off Wound Complications Post Operative
timeFrame: Up to 6 weeks Post OP
measure: Number of Participants With Thromboembolic Disease
timeFrame: Post Opeartive until the 6 week follow up appointment
measure: Quadriceps Strength Measure With a Handheld Dynamometer
timeFrame: Post Op day 1, 2 Week and 6 Week Post OP
measure: Time up and GO
timeFrame: preoperative appointment and once again at their 2 and 6 weeks postoperatively
measure: 30 Second STS Test
timeFrame: preoperative appointment and once again at their 2 and 6 weeks postoperatively
measure: Length of the Hospitalization
timeFrame: Daily up to 2 days while hospitalized
measure: Number of Patients Re-admitted Post TKA
timeFrame: up to 6 weeks post op
measure: Postoperative Pain Assessment Using Visual Analog Scale
timeFrame: 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)
measure: PONV (Post-operative Nausea and Vomiting)
timeFrame: Daily up to 2 days while hospitalized
measure: Veterans Rand -12
timeFrame: 2 week and 6 week follow up appointments
measure: Patient Reported Outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: pre-operatively as well as at their 2 week and 6 week follow up appointments
measure: Patient Reported Outcomes - Knee Society Score(KSS)
timeFrame: pre-operatively as well as at their 2 week and 6 week follow up appointments
measure: Total IV Fluids Received
timeFrame: Duration of IV intervention, up to 2 days
measure: Bioimpedence
timeFrame: pre-op visit, Post Op Day #1 as well as their 2 week and 6 week visit
Other outcomes:
measure: Number of Participants With Adverse Events
timeFrame: While in hospital until the 6 week follow up appointment
measure: Blood Pressure
timeFrame: Daily up to 2 days while hospitalized
measure: Total Number of Patients That Received Any Pressor Drugs
timeFrame: Up to Day 1 Post op
Locations:
city: Denver
country: United States
facility: Colorado Joint Replacement
state: Colorado
Study officials:
affiliation: Colorado Joint Replacement
name: Jason Jennings, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.