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The Effect of Low Dose Corticosteroids on Perioperative Markers of Thrombosis and Fibrinolysis in Total Knee Replacement

Information source: Hospital for Special Surgery, New York
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Total Knee Replacement

Intervention: Hydrocortisone (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hospital for Special Surgery, New York

Official(s) and/or principal investigator(s):
Kethy Jules-Elysée, M.D., Principal Investigator, Affiliation: Hospital for Special Surgery, New York

Summary

One postoperative complication following unilateral or bilateral total knee replacement is thrombosis (blood clot formation). In this prospective, double-blinded randomized controlled clinical trial, researchers are investigating the effect of steroids on biochemical markers of thrombosis. Furthermore, elevated cellular markers of thrombosis (specifically IL-6) have been linked to postoperative depression following total knee replacement surgery. Hence the investigators are also checking if use of hydrocortisone, a steroid, may help reduce the incidence of postoperative depression. Other studies have shown that surgery causes some reaction in the body that is consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body. It may also lead to clotting disorders and result in blood clots. In a previous study by this principal investigator (see reference 22, "Use of low-dose steroids in decreasing cytokine release during bilateral total knee replacement"), hydrocortisone was administered over 24 hours following surgery to patients who underwent bilateral total knee replacements. The investigator found lower levels of cellular markers consistent with inflammation (specifically the protein, IL-6). Steroid use also showed additional benefits, such as decreased pain and better range of motion at the knee. In this study, investigators recruit patients undergoing total knee replacement surgery. Patients are randomized to receive three 100 mg doses of hydrocortisone or three doses of a saline placebo. In addition to analyzing patients' blood samples for hydrocortisone's effect on clotting factors (i. e. IL-6), investigators record patients' pain scores and patients' oral analgesic use. To assess patients' well-being, patients are contacted one month and 3 months following their surgeries and administered the Patient Health Questionnaire (see reference 23, "The PHQ-9: validity of a brief depression severity measure.")

Clinical Details

Official title: The Effect of Low Dose Corticosteroids on Perioperative Markers of Thrombosis and Fibrinolysis in Total Knee Replacement

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Effect of hydrocortisone on thrombotic activity

Secondary outcome:

Hydrocortisone's effect on depression

Pain scores and opioid consumption

Blinding assessment

Eligibility

Minimum age: 50 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All patients undergoing unilateral or bilateral total knee replacement

- Age 50-90

Exclusion Criteria:

- All patients on steroid therapy regardless of dose or duration of treatment or those

requiring stress-dose steroids preoperatively

- Patients who are smokers

- Patients under 50 years of age

- Patients over 90 years of age

- Patients with diabetes

- Patients with a prior history of corticosteroid intolerance

- Patients with previous complications of steroid use

Locations and Contacts

Hospital for Special Surgery, New York, New York 10021, United States
Additional Information

This is a link to the Hospital for Special Surgery home page.

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Starting date: February 2011
Last updated: March 19, 2013

Page last updated: August 23, 2015

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