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

Hospital for Special Surgery (HSS)

Status: Completed

Conditions: Total Hip Replacement

Treatments: Drug: Placebo (for Prednisone); Drug: Prednisone; Drug: Hydrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT01782859

2012-008

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Control group

Treatment:

Drug: Placebo (for Prednisone)

Prednisone/hydrocortisone

Active Comparator group

Description:

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

Treatment:

Drug: Hydrocortisone

Drug: Prednisone