Osteoarthritis
Conditions
Keywords
Knee Arthroplasty, Hip Arthroplasty
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.
Detailed description
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.
Interventions
DRUGLactated Ringer
2L Lactated Ringer administered prior to primary knee or hip arthroplasty
DRUGPlacebo
No additional fluids will be administered
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Complications | 90 days post surgery | Patients found to have a 90-day postoperative complication categorized as Infection, CHF/Fluid overload, MI, DVT/PE, other |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 90 Day Readmission Count | 90 days postop | Patient readmitted to the hospital 90 day postoperatively |
| Duration of Hospital Stay (Hours) | Surgery to hospital discharge | Hours of Hospital Stay |
| Duration of Surgery | Incision to end of surgery | Minutes recorded for length of surgery |
| Emesis Episodes | Hospital Stay | Number of recorded emesis episodes in the medical record while patient was hospitalized |
| Volume of Fluid Administred | surgical period | milliliters of fluid administered during surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lactated Ringer Bolus Group Covered two liters of body temperature warmed lactated ringer's in the immediate preoperative setting of subjects undergoing total knee or total hip replacement
Lactated Ringer: 2L Lactated Ringer administered prior to primary knee or hip arthroplasty | 20 |
| Placebo Covered empty bag with no hydration supplement
Placebo: No additional fluids will be administered | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not given intervention | 2 | 0 |
| Overall Study | Surgery timing | 5 | 6 |
Baseline characteristics
| Characteristic | Lactated Ringer Bolus Group | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 6 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 33 Participants | 14 Participants |
| Region of Enrollment United States | 20 participants | 39 participants | 19 participants |
| Sex: Female, Male Female | 12 Participants | 17 Participants | 5 Participants |
| Sex: Female, Male Male | 8 Participants | 22 Participants | 14 Participants |
| Surgical Procedure Hip Replacement | 4 Participants | 15 Participants | 11 Participants |
| Surgical Procedure Knee Replacement | 16 Participants | 24 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
Primary
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
Population: Chart review for patients up to 90 days after surgery documenting the above complications.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lactated Ringer Bolus Group | Number of Participants With Postoperative Complications | Wound Infection | 0 participants |
| Lactated Ringer Bolus Group | Number of Participants With Postoperative Complications | CHF/Fluid Overload | 0 participants |
| Lactated Ringer Bolus Group | Number of Participants With Postoperative Complications | DVT/PE | 0 participants |
| Lactated Ringer Bolus Group | Number of Participants With Postoperative Complications | Other | 2 participants |
| Lactated Ringer Bolus Group | Number of Participants With Postoperative Complications | MI | 0 participants |
| Placebo | Number of Participants With Postoperative Complications | Other | 0 participants |
| Placebo | Number of Participants With Postoperative Complications | Wound Infection | 1 participants |
| Placebo | Number of Participants With Postoperative Complications | MI | 0 participants |
| Placebo | Number of Participants With Postoperative Complications | CHF/Fluid Overload | 0 participants |
| Placebo | Number of Participants With Postoperative Complications | DVT/PE | 0 participants |
Secondary
90 Day Readmission Count
Patient readmitted to the hospital 90 day postoperatively
Time frame: 90 days postop
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lactated Ringer Bolus Group | 90 Day Readmission Count | Readmission | 0 Participants |
| Lactated Ringer Bolus Group | 90 Day Readmission Count | No Readmission | 20 Participants |
| Placebo | 90 Day Readmission Count | Readmission | 1 Participants |
| Placebo | 90 Day Readmission Count | No Readmission | 18 Participants |
Secondary
Duration of Hospital Stay (Hours)
Hours of Hospital Stay
Time frame: Surgery to hospital discharge
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lactated Ringer Bolus Group | Duration of Hospital Stay (Hours) | 53.86 hours |
| Placebo | Duration of Hospital Stay (Hours) | 36.13 hours |
Secondary
Duration of Surgery
Minutes recorded for length of surgery
Time frame: Incision to end of surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lactated Ringer Bolus Group | Duration of Surgery | 122.68 Minutes |
| Placebo | Duration of Surgery | 126.3 Minutes |
Secondary
Emesis Episodes
Number of recorded emesis episodes in the medical record while patient was hospitalized
Time frame: Hospital Stay
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lactated Ringer Bolus Group | Emesis Episodes | 0.26 emesis episodes |
| Placebo | Emesis Episodes | 0.11 emesis episodes |
Secondary
Volume of Fluid Administred
milliliters of fluid administered during surgery
Time frame: surgical period
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lactated Ringer Bolus Group | Volume of Fluid Administred | 1635 milliliters |
| Placebo | Volume of Fluid Administred | 1518 milliliters |