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

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:

MedlinePlus related topics: Hip Replacement Steroids

Drug Information available for: Hydrocortisone acetate Hydrocortisone Prednisone Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone butyrate Hydrocortisone valerate Hydrocortisone probutate

U.S. FDA Resources

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: 20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital 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

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:

20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital
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

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:

Prednisone
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
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 May 23, 2013