Clinical Trials Directory

Trials / Completed

CompletedNCT03719378

Traditional vs Oral Fluid Management in Total Knee Arthroplasty

Traditional Intravenous Versus Oral Fluid Management in Total Knee Arthroplasty

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
150 (actual)
Sponsor
Colorado Joint Replacement · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
OTHERPre Operative Oral FluidsPatients will be self hydrating prior to their total knee replacement.

Timeline

Start date
2015-10-13
Primary completion
2018-09-10
Completion
2018-09-10
First posted
2018-10-25
Last updated
2021-03-16
Results posted
2021-03-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03719378. Inclusion in this directory is not an endorsement.