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Phase 4 N=30 Randomized Quadruple-blind Prevention

Steroids in Bilateral Total Knee Replacement

Postoperative Inflammatory Response

Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Decrease in IL6 Level — 359.4; 381.6 pg/ml

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Hydrocortisone (Drug); Saline (Drug)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
Hospital for Special Surgery, New York
Primary completion
Aug 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Decrease in IL6 Level
359.4; 381.6
SECONDARY
Desmosine Level
0; 0
SECONDARY
Blood Glucose
133; 102
SECONDARY
Length of Hospital Stay
5; 5
SECONDARY
In Hospital Infection Rate
0; 0
SECONDARY
Mortality
0; 0
SECONDARY
Ability to Ambulate
1; 1

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01399268). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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