Steroids in Bilateral Total Knee Replacement

July 27, 2017 updated by: Hospital for Special Surgery, New York

Effect of Steroids Given Over 24 Hours on Cytokine Release and Urinary Desmosine Levels in Patients Undergoing Bilateral Total Knee Replacement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital For Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Steroid
Hydrocortisone 100 mg IV Q 8hrs x3
Drug: Hydrocortisone
Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times
Placebo Comparator: Control
Saline IV Q8hr x3
Drug: Saline
Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in IL6 Level
Time Frame: 24 hours postoperative
24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Desmosine Level
Time Frame: 24 hours postoperative
24 hours postoperative
Blood Glucose
Time Frame: 24 hours postoperative
24 hours postoperative
Length of Hospital Stay
Time Frame: Length of hospital stay, an expected average of 5 days
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
Length of hospital stay, an expected average of 5 days
Mortality
Time Frame: Length of hospital stay, an expected average of 5 days
Length of hospital stay, an expected average of 5 days
Ability to Ambulate
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Investigators

  • Principal Investigator: Kethy Jules-Elysee, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 20, 2011

First Posted (Estimate)

July 21, 2011

Study Record Updates

Last Update Posted (Actual)

July 31, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSS-28116

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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