Traditional vs Oral Fluid Management in Total Knee Arthroplasty

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

Traditional Intravenous Versus Oral Fluid Management in Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719378
• Other study ID #: 1060593
• Status: Completed
• Phase: N/A
• Start date: October 13, 2015
• Est. completion date: September 10, 2018

Study information

• Verified date: February 2021
• Source: Colorado Joint Replacement
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 10, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Other:
• Pre Operative Oral Fluids
Patients will be self hydrating prior to their total knee replacement.

Locations

Country	Name	City	State
United States	Colorado Joint Replacement	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado Joint Replacement

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Blood Pressure	Blood Pressure (Diastolic/ Systolic)	Daily up to 2 days while hospitalized
Other	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
Primary	Body Weight	Patient Weight will be monitored	Change is patients weight from baseline at pre op to two weeks post op.
Secondary	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
Secondary	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
Secondary	Number of Participants With Requiring Transfusions	Post Operative/Intra Operative Transfusions	intra operative, Post Op Day #1 or #2
Secondary	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
Secondary	Number of Participants With Thromboembolic Disease	The incidence of thromboembolic events will be recorded.	Post Opeartive until the 6 week follow up appointment
Secondary	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
Secondary	Time up and GO	timed up and go (TUG)	preoperative appointment and once again at their 2 and 6 weeks postoperatively
Secondary	30 Second STS Test	30 second sit-to-stand tests	preoperative appointment and once again at their 2 and 6 weeks postoperatively
Secondary	Length of the Hospitalization	Length of time the patient is Hospitalized after their total knee replacement.	Daily up to 2 days while hospitalized
Secondary	Number of Patients Re-admitted Post TKA	Number of patients re-admitted post TKA	up to 6 weeks post op
Secondary	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)
Secondary	PONV (Post-operative Nausea and Vomiting)	patients will be asked about Nausea: None, Mild, Moderate or Severe	Daily up to 2 days while hospitalized
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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