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Steroids in Bilateral Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01399268
Recruitment Status : Completed
First Posted : July 21, 2011
Results First Posted : July 31, 2017
Last Update Posted : July 31, 2017
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Brief Summary:

Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a major marker of inflammation is known to increase during total joint replacement surgery. IL6 has been found to be elevated postoperatively in patients with hip fractures and has been linked to mental status changes and possibly other complications. It is known to lead to shock and participate in the inflammatory state seen in sepsis. High levels have further been linked to postoperative fever, confusion, symptoms of depression, acute respiratory distress syndrome (ARDS) and fat embolism syndrome (FES). Previously the investigators found that low dose steroids given in two doses in the initial perioperative period decreased the amount of IL6 released compared to placebo, but this was not sustained past 24 hours.

Desmosine is a stable breakdown product of elastin from lung tissue that can be measured in urine samples. It is considered to be a marker of lung injury and is found to be elevated in patients with ARDS, congestive obstructive pulmonary disease and FES. Previously, the investigators have found that urine desmosine levels rise with bilateral total knee replacement compared to unilateral total knee replacement indicating possible lung injury.

Therefore the investigators hypothesize:

Continued low dose steroids given three times over a 24 hour period will:

  1. Significantly decrease peak IL6 cytokine release during bilateral total knee replacement and maintaining this reduction in IL6 beyond 24 hours.
  2. Decrease urinary desmosine levels, and hence be protective of lung injury.

Condition or disease Intervention/treatment Phase
Postoperative Inflammatory Response Drug: Hydrocortisone Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Steroids Given Over 24 Hours on Cytokine Release and Urinary Desmosine Levels in Patients Undergoing Bilateral Total Knee Replacement
Study Start Date : February 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Steroid
Hydrocortisone 100 mg IV Q 8hrs x3
Drug: Hydrocortisone
Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times

Placebo Comparator: Control
Saline IV Q8hr x3
Drug: Saline
Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times

Primary Outcome Measures :
  1. Decrease in IL6 Level [ Time Frame: 24 hours postoperative ]

Secondary Outcome Measures :
  1. Desmosine Level [ Time Frame: 24 hours postoperative ]
  2. Blood Glucose [ Time Frame: 24 hours postoperative ]
  3. Length of Hospital Stay [ Time Frame: Length of hospital stay, an expected average of 5 days ]
  4. In Hospital Infection Rate [ Time Frame: Length of hospital stay, an expected average of 5 days ]
  5. Mortality [ Time Frame: Length of hospital stay, an expected average of 5 days ]
  6. Ability to Ambulate [ Time Frame: 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients scheduled for bilateral total knee replacement
  • Between 50-90 years of age

Exclusion Criteria:

  • Patients on steroid therapy
  • Patients that require stress-dose steroid pre-operatively
  • Patients that smoke
  • Patients that are diabetic
  • Patients younger than 50 or older than 90 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01399268

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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
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Principal Investigator: Kethy Jules-Elysee, MD Hospital for Special Surgery, New York

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Responsible Party: Hospital for Special Surgery, New York Identifier: NCT01399268     History of Changes
Other Study ID Numbers: HSS-28116
First Posted: July 21, 2011    Key Record Dates
Results First Posted: July 31, 2017
Last Update Posted: July 31, 2017
Last Verified: July 2017
Keywords provided by Hospital for Special Surgery, New York:
Bilateral total knee replacement
Additional relevant MeSH terms:
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Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents