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Steroids in Bilateral Total Knee Replacement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01399268
First received: July 14, 2011
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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.

Condition Intervention Phase
Postoperative Inflammatory Response
 Drug: Hydrocortisone
Drug: Saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Steroids Given Over 24 Hours on Cytokine Release and Urinary Desmosine Levels in Patients Undergoing Bilateral Total Knee Replacement

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Decrease in IL6 level [ Time Frame: 24 hours and 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Desmosine level [ Time Frame: 24 hours and 72 hours postoperative ] [ Designated as safety issue: Yes ]
  • Blood glucose [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: Yes ]
  • Hypoxemia [ Time Frame: Length of hospital stay, an expected average of 5 days ] [ Designated as safety issue: Yes ]
    As per arterial blood gas and need for mechanical ventilation

  • Length of hospital stay [ Time Frame: Length of hospital stay, an expected average of 5 days ] [ Designated as safety issue: No ]
  • In hospital infection rate [ Time Frame: Length of hospital stay, an expected average of 5 days ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: Length of hospital stay, an expected average of 5 days ] [ Designated as safety issue: Yes ]
  • Postoperative course [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Includes possible infection, thromboembolic disease, mortality, patient satisfaction

  • Postoperative Outcomes [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Postoperative pain (VAS), range of motion, ability to ambulate


Enrollment: 34
Study Start Date: February 2009
Study Completion Date: February 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399268

Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
Principal Investigator: Kethy Jules-Elysee, MD Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01399268     History of Changes
Other Study ID Numbers: HSS-28116
Study First Received: July 14, 2011
Last Updated: September 24, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Hospital for Special Surgery, New York:
Bilateral total knee replacement
cytokine
desmosine

Additional relevant MeSH terms:
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013