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

Not Applicable

Completed

Interventions: Drug: Placebo (for Prednisone)
Drug: Prednisone
Drug: Hydrocortisone

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (for Prednisone)	Control group
Prednisone/hydrocortisone	Prednisone	Steroid group will receive the following: 1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital 2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV
Prednisone/hydrocortisone	Hydrocortisone	Steroid group will receive the following: 1. 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital 2. 100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)	Participants will be followed from the time of surgery until discharge, expected average of 3-5 days	The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
Desmosine Level (Marker of Lung Injury)	Participants will be followed from the time of surgery until discharge, expected average of 3-5 days	The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital.
Pain at 3 Months Post-op	3 months postoperatively	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.