search
Back to results

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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lactated Ringer
Placebo
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis focused on measuring Knee Arthroplasty, Hip Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • WVU Medicine Department of Orthopaedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Drug Lactated Ringer

Placebo

Arm Description

Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement

Covered empty bag with no hydration supplement

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

90 Day Readmission Count
Patient readmitted to the hospital 90 day postoperatively
Duration of Hospital Stay (Hours)
Hours of Hospital Stay
Duration of Surgery
Minutes recorded for length of surgery
Emesis Episodes
Number of recorded emesis episodes in the medical record while patient was hospitalized
Volume of Fluid Administred
milliliters of fluid administered during surgery

Full Information

First Posted
December 18, 2015
Last Updated
November 4, 2020
Sponsor
West Virginia University
search

1. Study Identification

Unique Protocol Identification Number
NCT02638623
Brief Title
Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery
Acronym
Hydration
Official Title
Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery and Reduce Complications in Arthroplasty Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Knee Arthroplasty, Hip Arthroplasty

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug Lactated Ringer
Arm Type
Active Comparator
Arm Description
Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Covered empty bag with no hydration supplement
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer
Intervention Description
2L Lactated Ringer administered prior to primary knee or hip arthroplasty
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
No additional fluids will be administered
Primary Outcome Measure Information:
Title
Number of Participants With Postoperative Complications
Description
Patients found to have a 90-day postoperative complication categorized as Infection, CHF/Fluid overload, MI, DVT/PE, other
Time Frame
90 days post surgery
Secondary Outcome Measure Information:
Title
90 Day Readmission Count
Description
Patient readmitted to the hospital 90 day postoperatively
Time Frame
90 days postop
Title
Duration of Hospital Stay (Hours)
Description
Hours of Hospital Stay
Time Frame
Surgery to hospital discharge
Title
Duration of Surgery
Description
Minutes recorded for length of surgery
Time Frame
Incision to end of surgery
Title
Emesis Episodes
Description
Number of recorded emesis episodes in the medical record while patient was hospitalized
Time Frame
Hospital Stay
Title
Volume of Fluid Administred
Description
milliliters of fluid administered during surgery
Time Frame
surgical period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J Dietz, MD
Organizational Affiliation
West Virginia University Department of Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
WVU Medicine Department of Orthopaedics
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery

We'll reach out to this number within 24 hrs