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Studies have shown that surgery causes some reactions in your body consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body including the lungs. Corticosteroids are commonly used to treat inflammation and are different from performance enhancing steroids associated with athletics. The purpose of this study is to determine the influence of low dose steroids given 3 times in a 24 hour period on thrombotic markers (markers that are associated with increased risks of clotting, a possible complication of surgery), interleukin (IL)-6 cytokine release (part of the stress response seen with surgery), and urine desmosine levels (a marker of lung injury) in a randomized placebo controlled trial patients undergoing total hip replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Control group |
|
| Prednisone/hydrocortisone | Active Comparator | Steroid group will receive the following:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Prothrombin Fragment 1 and 2 (PF 1.2) | First 24 hours after surgery | |
| Plasmin-a 2 Antiplasmin Complex (PAP) | First 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. | Participants will be followed from the time of surgery until discharge, expected average of 3-5 days |
| Desmosine Level (Marker of Lung Injury) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Control group Placebo (for Prednisone) |
| FG001 | Prednisone/Hydrocortisone | Steroid group will receive the following:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Control group Placebo (for Prednisone) |
| BG001 | Prednisone/Hydrocortisone | Steroid group will receive the following:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Serum Prothrombin Fragment 1 and 2 (PF 1.2) | Posted | Mean | Standard Deviation | pmol/mL | First 24 hours after surgery |
|
|
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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 | Placebo | Control group Placebo (for Prednisone) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kethy Jules-Elysee, MD | Hospital for Special Surgery | 2126061206 | juleselyseek@hss.edu |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Hydrocortisone | Drug |
|
|
| Placebo (for Prednisone) | Drug |
|
|
The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. |
| Participants will be followed from the time of surgery until discharge, expected average of 3-5 days |
| Pain at 3 Months Post-op | At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain. | 3 months postoperatively |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/(m^2) |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Plasmin-a 2 Antiplasmin Complex (PAP) | Posted | Mean | Standard Deviation | mcg/L | First 24 hours after surgery |
|
|
|
| Secondary | Interleukin (IL)-6 Cytokine Release (Inflammatory Marker) | The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. | Posted | Mean | Standard Deviation | picograms/milliliter | Participants will be followed from the time of surgery until discharge, expected average of 3-5 days |
|
|
|
| Secondary | Desmosine Level (Marker of Lung Injury) | The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. | Desmosine levels were not analyzed. | Posted | Participants will be followed from the time of surgery until discharge, expected average of 3-5 days |
|
|
| Secondary | Pain at 3 Months Post-op | At 3 months postoperatively, patients were asked to rate their pain on a scale of 0-10, with 0 being no pain and 10 being worst pain. | Posted | Mean | Standard Deviation | units on a scale | 3 months postoperatively |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Prednisone/Hydrocortisone | Steroid group will receive the following:
| 0 | 20 | 0 | 20 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| 4 hours postoperatively |
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| 6 hours postoperatively |
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| 24 hours postoperatively |
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| 4 hours postoperatively |
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| 6 hours postoperatively |
|
| 24 hours postoperatively |
|