Traditional vs Oral Fluid Management in Total Knee Arthroplasty

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-13

Study Completion Date

2018-09-10

Brief Summary

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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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Detailed Description

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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

Conditions

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Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Pre Operative Oral Fluids

Intervention Type OTHER

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

Interventions

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Pre Operative Oral Fluids

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes