Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery

Osteoarthritis Clinical Trial

— Hydration  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02638623
• Other study ID #: 1502590723
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: November 2020
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Lactated Ringer
2L Lactated Ringer administered prior to primary knee or hip arthroplasty
• Placebo
No additional fluids will be administered

Locations

Country	Name	City	State
United States	WVU Medicine Department of Orthopaedics	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

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