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NCT Number: NCT01782859

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

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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Key information

Conditions

Total Hip Replacement

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisone

Drug

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

Hydrocortisone

Drug

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

Placebo (for prednisone)

Drug

Other names: Lactose filler to mimic 20 mg prednisone tablet

Primary outcomes

  1. Serum Prothrombin Fragment 1 and 2 (PF 1.2)

    Time frame: First 24 hours after surgery

  2. Plasmin-a 2 Antiplasmin Complex (PAP)

    Time frame: First 24 hours after surgery

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 4, 2013
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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