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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Covered empty bag with no hydration supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactated Ringer | Drug | 2L Lactated Ringer administered prior to primary knee or hip arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 90 Day Readmission Count | Patient readmitted to the hospital 90 day postoperatively | 90 days postop |
| Duration of Hospital Stay (Hours) | Hours of Hospital Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J Dietz, MD | West Virginia University Department of Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVU Medicine Department of Orthopaedics | Morgantown | West Virginia | 26506 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Covered empty bag with no hydration supplement Placebo: No additional fluids will be administered |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Chart review for patients up to 90 days after surgery documenting the above complications. | Posted | Number | participants | 90 days post surgery |
|
90 Days postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew J. Dietz, MD | West Virginia University Department of Orthopaedics | 304-285-7445 | mdietz@hsc.wvu.edu |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Placebo | Drug | No additional fluids will be administered |
|
|
| Surgery to hospital discharge |
| Duration of Surgery | Minutes recorded for length of surgery | Incision to end of surgery |
| Emesis Episodes | Number of recorded emesis episodes in the medical record while patient was hospitalized | Hospital Stay |
| Volume of Fluid Administred | milliliters of fluid administered during surgery | surgical period |
| Placebo |
Covered empty bag with no hydration supplement Placebo: No additional fluids will be administered |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs. | Count of Participants | Participants |
|
| Region of Enrollment | 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs. | Number | participants |
|
| Surgical Procedure | 52 participants were initially enrolled. Patients that did not have surgery were removed from the analysis. Also, there were a few instances where there was not adequate staffing to fulfill the protocols needs. | Count of Participants | Participants |
|
Covered empty bag with no hydration supplement
Placebo: No additional fluids will be administered
|
|
| Secondary | 90 Day Readmission Count | Patient readmitted to the hospital 90 day postoperatively | Posted | Count of Participants | Participants | 90 days postop |
|
|
|
| Secondary | Duration of Hospital Stay (Hours) | Hours of Hospital Stay | Posted | Mean | Full Range | hours | Surgery to hospital discharge |
|
|
|
| Secondary | Duration of Surgery | Minutes recorded for length of surgery | Posted | Mean | Full Range | Minutes | Incision to end of surgery |
|
|
|
| Secondary | Emesis Episodes | Number of recorded emesis episodes in the medical record while patient was hospitalized | Posted | Mean | Full Range | emesis episodes | Hospital Stay |
|
|
|
| Secondary | Volume of Fluid Administred | milliliters of fluid administered during surgery | Posted | Mean | Full Range | milliliters | surgical period |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo | Covered empty bag with no hydration supplement Placebo: No additional fluids will be administered | 0 | 19 | 0 | 19 | 0 | 19 |
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| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |