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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Hospital for Special Surgery, New York
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01782859
First received: January 28, 2013
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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), 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.


Condition Intervention
Total Hip Replacement
Drug: Prednisone
Drug: Hydrocortisone
Drug: Placebo (for Prednisone)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Steroids Given Over 24 Hours on Cytokine Release, Urinary Desmosine Level and Thrombogenic Markers in Patients Undergoing Unilateral Total Hip Replacement

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Serum prothrombin fragment 1 and 2 (PF 1.2) [ Time Frame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days ] [ Designated as safety issue: No ]
    The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. We will also contact the subject at 3 and 6 months after discharge to ask questions about their health and recovery

  • Plasmin-a 2 antiplasmin complex (PAP) [ Time Frame: Participants will be followed from the time of surgery until discharge, expected average of 3-5 days ] [ Designated as safety issue: No ]
    The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. We will also contact the subject at 3 and 6 months after discharge to ask questions about their health and recovery


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. We will also contact the subject at 3 and 6 months after discharge to ask questions about their health and recovery

  • 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 ] [ Designated as safety issue: No ]
    The time frame of the study for each patient covers the period between time of surgery and until discharge from the hospital. We will also contact the subject at 3 and 6 months after discharge to ask questions about their health and recovery


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Control group
Drug: Placebo (for Prednisone)
Other Name: 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
Drug: Prednisone
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
Drug: Hydrocortisone
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

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01782859

Contacts
Contact: Kethy Jules-Elysee, MD 212-606-1206 JulesElyseeK@hss.edu

Locations
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Kethy Jules-Elysee, MD    212-606-1206    JulesElyseeK@hss.edu   
Sponsors and Collaborators
Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01782859     History of Changes
Other Study ID Numbers: 2012-008
Study First Received: January 28, 2013
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Prednisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014