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

NCT01782859 | Completed Results

• 1 other identifier: 2012-008
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Hip Replacement

Outcome Measures

Primary Outcomes (2)

• Serum Prothrombin Fragment 1 and 2 (PF 1.2)

  First 24 hours after surgery

• Plasmin-a 2 Antiplasmin Complex (PAP)

  First 24 hours after surgery

Secondary Outcomes (3)

• Interleukin (IL)-6 Cytokine Release (Inflammatory Marker)

  Participants will be followed from the time of surgery until discharge, expected average of 3-5 days

• Desmosine Level (Marker of Lung Injury)

  Participants will be followed from the time of surgery until discharge, expected average of 3-5 days

• Pain at 3 Months Post-op

  3 months postoperatively

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Control group

Drug: Placebo (for Prednisone)

Prednisone/hydrocortisone

ACTIVE COMPARATOR

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; Drug: Hydrocortisone

Interventions

Prednisone DRUG

Also known as: 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

Prednisone/hydrocortisone

Hydrocortisone DRUG

Also known as: 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

Prednisone/hydrocortisone

Placebo (for Prednisone) DRUG

Also known as: Lactose filler to mimic 20 mg prednisone tablet

Placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing unilateral total hip replacement with Drs. Douglas Padgett, Thomas Sculco, or Edwin Su.
• Patients between the age of 50 and 90

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Prednisone; Hydrocortisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Results Point of Contact

• Title: Kethy Jules-Elysee, MD
• Organization: Hospital for Special Surgery

juleselyseek@hss.edu

2126061206

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: February 4, 2013
• Study Start: October 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 5, 2017
• Results First Posted: May 10, 2016

Record last verified: 2016-07

Locations

US (1)