Clinical trial NCT01399268: Steroids in Bilateral Total Knee Replacement
Official title: Effect of Steroids Given Over 24 Hours on Cytokine Release and Urinary Desmosine Levels in Patients Undergoing Bilateral Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Inflammatory Response
Keywords: Bilateral total knee replacement
cytokine
desmosine
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2011-07-21
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Decrease in IL6 Level
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Desmosine Level
timeFrame: 24 hours postoperative
measure: Blood Glucose
timeFrame: 24 hours postoperative
measure: Length of Hospital Stay
timeFrame: Length of hospital stay, an expected average of 5 days
measure: In Hospital Infection Rate
timeFrame: Length of hospital stay, an expected average of 5 days
measure: Mortality
timeFrame: Length of hospital stay, an expected average of 5 days
measure: Ability to Ambulate
timeFrame: 48 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Kethy Jules-Elysee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.