Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery (Hydration)
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ClinicalTrials.gov Identifier: NCT02638623 |
Recruitment Status :
Completed
First Posted : December 23, 2015
Results First Posted : October 23, 2020
Last Update Posted : November 20, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoarthritis | Drug: Lactated Ringer Drug: Placebo | Not Applicable |
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 |

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
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Drug: Lactated Ringer
2L Lactated Ringer administered prior to primary knee or hip arthroplasty |
Placebo Comparator: Placebo
Covered empty bag with no hydration supplement
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Drug: Placebo
No additional fluids will be administered
Other Name: Saline |
- 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
- 90 Day Readmission Count [ Time Frame: 90 days postop ]Patient readmitted to the hospital 90 day postoperatively
- Duration of Hospital Stay (Hours) [ Time Frame: Surgery to hospital discharge ]Hours of Hospital Stay
- Duration of Surgery [ Time Frame: Incision to end of surgery ]Minutes recorded for length of surgery
- Emesis Episodes [ Time Frame: Hospital Stay ]Number of recorded emesis episodes in the medical record while patient was hospitalized
- Volume of Fluid Administred [ Time Frame: surgical period ]milliliters of fluid administered during surgery

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638623
United States, West Virginia | |
WVU Medicine Department of Orthopaedics | |
Morgantown, West Virginia, United States, 26506 |
Principal Investigator: | Matthew J Dietz, MD | West Virginia University Department of Orthopaedics |
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 Key Record Dates |
Results First Posted: | October 23, 2020 |
Last Update Posted: | November 20, 2020 |
Last Verified: | November 2020 |
Knee Arthroplasty Hip Arthroplasty |
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |