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

• ClinicalTrials.gov Identifier: NCT02638623
• Recruitment Status: Completed
• First Posted: December 23, 2015
• Results First Posted: October 23, 2020
• Last Update Posted: November 20, 2020
• Sponsor: West Virginia University
• Information provided by (Responsible Party): Matthew Dietz, MD, West Virginia University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, West Virginia

WVU Medicine Department of Orthopaedics

Morgantown, West Virginia, United States, 26506

Sponsors and Collaborators

West Virginia University

Investigators

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

More Information

• Responsible Party: Matthew Dietz, MD, Assistant Professor, MD, West Virginia University
• ClinicalTrials.gov Identifier: NCT02638623
• Other Study ID Numbers: 1502590723
• First Posted: December 23, 2015
• 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:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases