Traditional vs Oral Fluid Management in Total Knee Arthroplasty
Completed · Not applicable
Conditions studied: Arthroplasty, Replacement, Knee
In brief
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.
Key facts
- Study ID
- NCT03719378
- Run by
- Colorado Joint Replacement
- People needed
- 150
- Starts
- 2015-10-13
- Expected to finish
- 2018-09-10
- Last updated by the study team
- 2021-03-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Colorado Joint Replacement — Denver, Colorado, United States
Full record on ClinicalTrials.gov
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