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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Lactated Ringer; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • WVU Medicine Department of Orthopaedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Saline

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: West Virginia University
• Investigators: Principal Investigator: Matthew J Dietz, MD, West Virginia University Department of Orthopaedics

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: December 18, 2015
• First Submitted That Met QC Criteria: December 22, 2015
• First Posted (Estimate): December 23, 2015

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Knee Arthroplasty; Hip Arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 1502590723