Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery and Reduce Complications in Arthroplasty Patients?

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Lactated Ringer
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug Lactated Ringer<br>Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement | Drug: Lactated Ringer<br>* 2L Lactated Ringer administered prior to primary knee or hip arthroplasty<br>|
| Placebo Comparator: Placebo<br>Covered empty bag with no hydration supplement | Drug: Placebo<br>* No additional fluids will be administered<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postoperative Complications | Patients found to have a 90-day postoperative complication categorized as Infection, CHF/Fluid overload, MI, DVT/PE, other | 90 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90 Day Readmission Count | Patient readmitted to the hospital 90 day postoperatively | 90 days postop | 
| Duration of Hospital Stay (Hours) | Hours of Hospital Stay | Surgery to hospital discharge | 
| Duration of Surgery | Minutes recorded for length of surgery | Incision to end of surgery | 
| Emesis Episodes | Number of recorded emesis episodes in the medical record while patient was hospitalized | Hospital Stay | 
| Volume of Fluid Administred | milliliters of fluid administered during surgery | surgical period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Arthroplasty, Hip Arthroplasty