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Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery (Hydration)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02638623
Recruitment Status : Completed
First Posted : December 23, 2015
Results First Posted : October 23, 2020
Last Update Posted : November 20, 2020
Information provided by (Responsible Party):
Matthew Dietz, MD, 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Lactated Ringer Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery and Reduce Complications in Arthroplasty Patients?
Study Start Date : October 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Drug Lactated Ringer
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
2L Lactated Ringer administered prior to primary knee or hip arthroplasty

Placebo Comparator: Placebo
Covered empty bag with no hydration supplement
Drug: Placebo
No additional fluids will be administered
Other Name: Saline

Primary Outcome Measures :
  1. Number of Participants With Postoperative Complications [ Time Frame: 90 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 :
  1. 90 Day Readmission Count [ Time Frame: 90 days postop ]
    Patient readmitted to the hospital 90 day postoperatively

  2. Duration of Hospital Stay (Hours) [ Time Frame: Surgery to hospital discharge ]
    Hours of Hospital Stay

  3. Duration of Surgery [ Time Frame: Incision to end of surgery ]
    Minutes recorded for length of surgery

  4. Emesis Episodes [ Time Frame: Hospital Stay ]
    Number of recorded emesis episodes in the medical record while patient was hospitalized

  5. Volume of Fluid Administred [ Time Frame: surgical period ]
    milliliters of fluid administered during surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02638623

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United States, West Virginia
WVU Medicine Department of Orthopaedics
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
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Principal Investigator: Matthew J Dietz, MD West Virginia University Department of Orthopaedics
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Responsible Party: Matthew Dietz, MD, Assistant Professor, MD, West Virginia University Identifier: NCT02638623    
Other Study ID Numbers: 1502590723
First Posted: December 23, 2015    Key Record Dates
Results First Posted: October 23, 2020
Last Update Posted: November 20, 2020
Last Verified: November 2020
Keywords provided by Matthew Dietz, MD, West Virginia University:
Knee Arthroplasty
Hip Arthroplasty
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases