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Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery

NCT ID: NCT02638623

Last Updated: 2020-11-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Keywords

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Knee Arthroplasty Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Lactated Ringer

Intervention Type DRUG

2L Lactated Ringer administered prior to primary knee or hip arthroplasty

Placebo

Covered empty bag with no hydration supplement

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

No additional fluids will be administered

Interventions

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Lactated Ringer

2L Lactated Ringer administered prior to primary knee or hip arthroplasty

Intervention Type DRUG

Placebo

No additional fluids will be administered

Intervention Type DRUG

Other Intervention Names

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Saline

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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Matthew Dietz, MD

Assistant Professor, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew J Dietz, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University Department of Orthopaedics

Locations

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WVU Medicine Department of Orthopaedics

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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1502590723

Identifier Type: -

Identifier Source: org_study_id