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Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery

Not Applicable
Completed
Conditions
Osteoarthritis
Interventions
Drug: Lactated Ringer
Drug: Placebo
Registration Number
NCT02638623
Lead Sponsor
West Virginia University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
52
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Drug Lactated RingerLactated RingerCovered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement
PlaceboPlaceboCovered empty bag with no hydration supplement
Primary Outcome Measures
NameTimeMethod
Number of Participants With Postoperative Complications90 days post surgery

Patients found to have a 90-day postoperative complication categorized as Infection, CHF/Fluid overload, MI, DVT/PE, other

Secondary Outcome Measures
NameTimeMethod
Volume of Fluid Administredsurgical period

milliliters of fluid administered during surgery

90 Day Readmission Count90 days postop

Patient readmitted to the hospital 90 day postoperatively

Duration of SurgeryIncision to end of surgery

Minutes recorded for length of surgery

Emesis EpisodesHospital Stay

Number of recorded emesis episodes in the medical record while patient was hospitalized

Duration of Hospital Stay (Hours)Surgery to hospital discharge

Hours of Hospital Stay

Trial Locations

Locations (1)

WVU Medicine Department of Orthopaedics

🇺🇸

Morgantown, West Virginia, United States

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