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

November 7, 2016 updated by: Hospital for Special Surgery, New York

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Control group
Other Names:
  • Lactose filler to mimic 20 mg prednisone tablet
Active Comparator: 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
Other Names:
  • 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
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Prothrombin Fragment 1 and 2 (PF 1.2)
Time Frame: First 24 hours after surgery
First 24 hours after surgery
Plasmin-a 2 Antiplasmin Complex (PAP)
Time Frame: First 24 hours after surgery
First 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)
Time Frame: 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.
Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
Desmosine Level (Marker of Lung Injury)
Time Frame: 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.
Participants will be followed from the time of surgery until discharge, expected average of 3-5 days
Pain at 3 Months Post-op
Time Frame: 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.
3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimate)

February 4, 2013

Study Record Updates

Last Update Posted (Estimate)

January 5, 2017

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

July 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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