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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-01-31

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.

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Detailed Description

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Conditions

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Total Hip Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Control group

Group Type PLACEBO_COMPARATOR

Placebo (for Prednisone)

Intervention Type DRUG

Prednisone/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

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type DRUG

Hydrocortisone

Intervention Type DRUG

Interventions

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Prednisone

Intervention Type DRUG

Hydrocortisone

Intervention Type DRUG

Placebo (for Prednisone)

Intervention Type DRUG

Other Intervention Names

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Low dose steroids to be administered preoperatively and then repeated over a 24-hour period 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. Another dose of 100 mg hydrocortisone IV 8 hours after Low dose steroids to be administered preoperatively and then repeated over a 24-hour period 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. Another dose of 100 mg hydrocortisone IV 8 hours after Lactose filler to mimic 20 mg prednisone tablet

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes