Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement

Conditions
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Total Hip Replacement

Intervention / Treatment
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* Drug: Prednisone
* Drug: Hydrocortisone
* Drug: Placebo (for Prednisone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing unilateral total hip replacement with Drs. Douglas Padgett, Thomas Sculco, or Edwin Su. Patients between the age of 50 and 90 Exclusion Criteria: Patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively Patients who are smokers Patients who have diabetes Patients who are <50 and >90 years of age Patients with history of prior difficulties tolerating corticosteroids

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Control group | Drug: Placebo (for Prednisone)<br> <br> * Other names: Lactose filler to mimic 20 mg prednisone tablet;|
| Active Comparator: Prednisone/hydrocortisone<br>Steroid group will receive the following: 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV | Drug: Prednisone<br> <br> * Other names: 3. Another dose of 100 mg hydrocortisone IV 8 hours after;Drug: Hydrocortisone<br> <br> * Other names: 3. Another dose of 100 mg hydrocortisone IV 8 hours after;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |