Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery

NCT02638623 | Completed Results DMC

• 1 other identifier: 1502590723
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Knee Arthroplasty; Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 90 Day Readmission Count

  90 days postop

• Duration of Hospital Stay (Hours)

  Surgery to hospital discharge

• Duration of Surgery

  Incision to end of surgery

• Emesis Episodes

  Hospital Stay

• Volume of Fluid Administred

  surgical period

Study Arms (2)

Drug Lactated Ringer

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Covered empty bag with no hydration supplement

Drug: Placebo

Interventions

Lactated Ringer DRUG

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

Drug Lactated Ringer

Placebo DRUG

No additional fluids will be administered

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients \>= 18 years of age, undergoing a total primary knee or hip arthroplasty

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

WVU Medicine Department of Orthopaedics

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Ringer's Lactate; Sodium Chloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Matthew J. Dietz, MD
• Organization: West Virginia University Department of Orthopaedics

mdietz@hsc.wvu.edu

304-285-7445

Study Officials

• Matthew J Dietz, MD

  West Virginia University Department of Orthopaedics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, MD

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 23, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 20, 2020
• Results First Posted: October 23, 2020

Record last verified: 2020-11

Locations

US (1)