Steroids in Bilateral Total Knee Replacement
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|ClinicalTrials.gov Identifier: NCT01399268|
Recruitment Status : Completed
First Posted : July 21, 2011
Results First Posted : July 31, 2017
Last Update Posted : July 31, 2017
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:
- Significantly decrease peak IL6 cytokine release during bilateral total knee replacement and maintaining this reduction in IL6 beyond 24 hours.
- 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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Hydrocortisone 100 mg IV Q 8hrs x3
Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times
Placebo Comparator: Control
Saline IV Q8hr x3
Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
- Decrease in IL6 Level [ Time Frame: 24 hours postoperative ]
- Desmosine Level [ Time Frame: 24 hours postoperative ]
- Blood Glucose [ Time Frame: 24 hours postoperative ]
- Length of Hospital Stay [ Time Frame: Length of hospital stay, an expected average of 5 days ]
- In Hospital Infection Rate [ Time Frame: Length of hospital stay, an expected average of 5 days ]
- Mortality [ Time Frame: Length of hospital stay, an expected average of 5 days ]
- Ability to Ambulate [ Time Frame: 48 hours ]
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 ClinicalTrials.gov identifier (NCT number): NCT01399268
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Kethy Jules-Elysee, MD||Hospital for Special Surgery, New York|