An interventional study of Lactated Ringer and Placebo in Osteoarthritis, sponsored by West Virginia University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-20.
Sponsored by West Virginia University · Not applicable, Interventional, and Prevention
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 52 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →West Virginia University is the lead sponsor of 155 studies on the registry; 35 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Covered empty bag with no hydration supplement
Drug: Placebo
2L Lactated Ringer administered prior to primary knee or hip arthroplasty
No additional fluids will be administered
Also known as: Saline
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
Time frame: 90 days post surgery
90 Day Readmission Count
Patient readmitted to the hospital 90 day postoperatively
Time frame: 90 days postop
Duration of Hospital Stay (Hours)
Hours of Hospital Stay
Time frame: Surgery to hospital discharge
Duration of Surgery
Minutes recorded for length of surgery
Time frame: Incision to end of surgery
Emesis Episodes
Number of recorded emesis episodes in the medical record while patient was hospitalized
Time frame: Hospital Stay
Volume of Fluid Administred
milliliters of fluid administered during surgery
Time frame: surgical period
| Milestone | Lactated Ringer Bolus Group | Placebo |
|---|---|---|
| Started | 27 | 25 |
| Completed | 20 | 19 |
| Not completed | 7 | 6 |
| Withdrew: Surgery timing | 5 | 6 |
| Withdrew: Not given intervention | 2 | 0 |
Patients found to have a 90-day postoperative complication categorized as Infection, CHF/Fluid overload, MI, DVT/PE, other
| participants | Lactated Ringer Bolus Group | Placebo |
|---|---|---|
| Wound Infection | 0 | 1 |
| DVT/PE | 0 | 0 |
| MI | 0 | 0 |
| CHF/Fluid Overload | 0 | 0 |
| Other | 2 | 0 |
Patient readmitted to the hospital 90 day postoperatively
| Participants | Lactated Ringer Bolus Group | Placebo |
|---|---|---|
| Readmission | 0 | 1 |
| No Readmission | 20 | 18 |
Hours of Hospital Stay
| hours | Lactated Ringer Bolus Group | Placebo |
|---|---|---|
| Duration of Hospital Stay (Hours) | 53.86 (26 to 169) | 36.13 (24 to 78) |
Minutes recorded for length of surgery
| Minutes | Lactated Ringer Bolus Group | Placebo |
|---|---|---|
| Duration of Surgery | 122.68 (87 to 172) | 126.3 (102 to 158) |
Number of recorded emesis episodes in the medical record while patient was hospitalized
| emesis episodes | Lactated Ringer Bolus Group | Placebo |
|---|---|---|
| Emesis Episodes | 0.26 (0 to 2) | 0.11 (0 to 1) |
milliliters of fluid administered during surgery
| milliliters | Lactated Ringer Bolus Group | Placebo |
|---|---|---|
| Volume of Fluid Administred | 1635 (400 to 4750) | 1518 (700 to 2600) |
Collected over 90 Days postoperatively. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lactated Ringer Bolus Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Placebo | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Lactated Ringer Bolus Group | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 14 | 33 |
| >=65 years | 1 | 5 | 6 |
| Sex: Female, Male(Participants) | Lactated Ringer Bolus Group | Placebo | Total |
|---|---|---|---|
| Female | 12 | 5 | 17 |
| Male | 8 | 14 | 22 |
| Region of Enrollment(participants) | Lactated Ringer Bolus Group | Placebo | Total |
|---|---|---|---|
| United States | 20 | 19 | 39 |
| Surgical Procedure(Participants) | Lactated Ringer Bolus Group | Placebo | Total |
|---|---|---|---|
| Hip Replacement | 4 | 11 | 15 |
| Knee Replacement | 16 | 8 | 24 |
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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