Clinical trial NCT02638623: Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery
Official title: Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery and Reduce Complications in Arthroplasty Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Knee Arthroplasty
Hip Arthroplasty
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2015-12-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are testing the hypothesis that administering 2L of body temperature warmed lactated ringer's intravenously prior to surgery can optimize the postoperative and recovery of patients undergoing total hip and total knee arthroplasty.

Detailed description: Hip and knee arthroplasty are safe and reliable surgeries for the majority of patients, but a small percentage experience major complications such as myocardial infarction, deep vein thrombosis (DVT), and pulmonary embolism (PE). As these complications are related to local tissue hypoxemia and patient immobility, interventions that can improve the ability of the heart to deliver blood to the tissue and help patients mobilize earlier in their postoperative course may decrease these complications. Based on recent evidence, it has been shown that many patients are dehydrated before surgery, which can make them feel nauseous, tired, and increase their perception of pain making them less likely to mobilize. This predisposes them to DVTs, pulmonary embolism, nausea and vomiting. Peri-operative dehydration can also decrease the ability of the lungs to oxygenate the blood properly and can place additional stress on the heart, which can increase the risk of heart attacks. The specific aim is to determine if patients' peri-operative hemodynamics can be improved with preoperative administration of 2 L of lactated ringers, and consequently reduce postoperative complications and improve recovery in arthroplasty patients.

Eligibility criteria: Inclusion Criteria:

* All patients \>= 18 years of age, undergoing a total primary knee or hip arthroplasty

Exclusion Criteria:

* Patients weighing less than 80 kg.
* Patients undergoing irrigation and debridement, explantation, or revision will not be eligible.
* history of kidney disease, congestive heart failure, pulmonary edema, cirrhosis of the liver, or history of systemic fluid overloard will be excluded from the study.
* No one will be excluded based on gender, ethnicity or race.

Primary outcomes:
measure: Number of Participants With Postoperative Complications
timeFrame: 90 days post surgery
Secondary outcomes:
measure: 90 Day Readmission Count
timeFrame: 90 days postop
measure: Duration of Hospital Stay (Hours)
timeFrame: Surgery to hospital discharge
measure: Duration of Surgery
timeFrame: Incision to end of surgery
measure: Emesis Episodes
timeFrame: Hospital Stay
measure: Volume of Fluid Administred
timeFrame: surgical period
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: WVU Medicine Department of Orthopaedics
state: West Virginia
Study officials:
affiliation: West Virginia University Department of Orthopaedics
name: Matthew J Dietz, MD
role: PRINCIPAL_INVESTIGATOR
References: