Steroids in Bilateral Total Knee Replacement

NCT01399268 | Completed Phase 4 Results

• 1 other identifier: HSS-28116
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 1.Significantly decrease peak IL6 cytokine release during bilateral total knee replacement and maintaining this reduction in IL6 beyond 24 hours.
2. 2.Decrease urinary desmosine levels, and hence be protective of lung injury.

Conditions

Postoperative Inflammatory Response

Keywords

Bilateral total knee replacement; cytokine; desmosine

Outcome Measures

Primary Outcomes (1)

• Decrease in IL6 Level

  24 hours postoperative

Secondary Outcomes (6)

• Desmosine Level

  24 hours postoperative

• Blood Glucose

  24 hours postoperative

• Length of Hospital Stay

  Length of hospital stay, an expected average of 5 days

• In Hospital Infection Rate

  Length of hospital stay, an expected average of 5 days

• Mortality

  Length of hospital stay, an expected average of 5 days

Study Arms (2)

Steroid

EXPERIMENTAL

Hydrocortisone 100 mg IV Q 8hrs x3

Drug: Hydrocortisone

Control

PLACEBO COMPARATOR

Saline IV Q8hr x3

Drug: Saline

Interventions

Hydrocortisone DRUG

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

Steroid

Saline DRUG

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

Control

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for bilateral total knee replacement
• Between 50-90 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (1)

• McLawhorn AS, Poultsides LA, Sakellariou VI, Kunze KN, Fields KG, Jules-Elysee K, Sculco TP. Low-Dose Perioperative Corticosteroids Can Be Administered Without Additional Morbidity in Patients Undergoing Bilateral Total Knee Replacement: A Retrospective Follow-up Study of a Randomized Controlled Trial. HSS J. 2022 Feb;18(1):48-56. doi: 10.1177/15563316211006098. Epub 2021 Apr 9.

  PMID: 35087332 DERIVED

MeSH Terms

Interventions

Hydrocortisone; Sodium Chloride

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Jules
• Organization: HSS

JulesK@hss.edu

212.606.1206

Study Officials

• Kethy Jules-Elysee, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 21, 2011
• Study Start: February 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: February 1, 2011
• Last Updated: July 31, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-07

Locations

US (1)