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OpenTrials
Completed

NCT Number: NCT02638623

Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WVU Medicine Department of Orthopaedics

Morgantown, West Virginia, 26506, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactated Ringer

Drug

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

Placebo

Drug

No additional fluids will be administered

Other names: Saline

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

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

Acronym: Hydration

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2015
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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