Effect of Steroids Given Over 24 Hours on Cytokine Release and Urinary Desmosine Levels in Patients Undergoing Bilateral Total Knee Replacement
Sponsor study identifier
interventional
30
1 country
1
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2010
Actual (reported)Study Completion
February 2011
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
August 2010
Actual (reported)February 2011
Actual (reported)July 14, 2011
Actual (reported)July 21, 2011
Actual (reported)July 31, 2017
Actual (reported)Decrease in IL6 Level
24 hours postoperative
Desmosine Level
24 hours postoperative
Blood Glucose
24 hours postoperative
Length of Hospital Stay
Length of hospital stay, an expected average of 5 days
In Hospital Infection Rate
Length of hospital stay, an expected average of 5 days
Mortality
Length of hospital stay, an expected average of 5 days
Hydrocortisone 100 mg IV Q 8hrs x3
Saline IV Q8hr x3
Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times
Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital for Special Surgery
New York, New York, 10021, United States
McLawhorn AS, Poultsides LA, Sakellariou VI, Kunze KN, Fields KG, Jules-Elysee K, Sculco TP. Low-Dose Perioperative Corticosteroids Can Be Administered Without Additional Morbidity in Patients Undergoing Bilateral Total Knee Replacement: A Retrospective Follow-up Study of a Randomized Controlled Trial. HSS J. 2022 Feb;18(1):48-56. doi: 10.1177/15563316211006098. Epub 2021 Apr 9.
Kethy Jules-Elysee, MD
Hospital for Special Surgery, New York
30 participants (actual enrollment reported by the registry).
First Submitted
July 14, 2011
First Posted
July 21, 2011
Study Start
February 2009
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
August 2010
Actual (reported)Study Completion
February 2011
Actual (reported)Last Updated
July 31, 2017
Results First Posted
July 31, 2017
Record last verified: 2017-07
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