Steroids in Bilateral Total Knee Replacement

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Postoperative Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Steroid

Hydrocortisone 100 mg IV Q 8hrs x3

Group Type EXPERIMENTAL

Hydrocortisone

Intervention Type DRUG

Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times

Control

Saline IV Q8hr x3

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times

Interventions

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Hydrocortisone

Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times

Intervention Type DRUG

Saline

Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No