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Completed

NCT Number: NCT01399268

Steroids in 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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrocortisone

Drug

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

Saline

Drug

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

Primary outcomes

  1. Decrease in IL6 Level

    Time frame: 24 hours postoperative

Secondary outcomes

  1. Desmosine Level

    Time frame: 24 hours postoperative

  2. Blood Glucose

    Time frame: 24 hours postoperative

  3. Length of Hospital Stay

    Time frame: Length of hospital stay, an expected average of 5 days

  4. In Hospital Infection Rate

    Time frame: Length of hospital stay, an expected average of 5 days

  5. Mortality

    Time frame: Length of hospital stay, an expected average of 5 days

  6. Ability to Ambulate

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Jul 21, 2011
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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