Postoperative Inflammatory ResponsePhase 4NCT01399268
Steroids in Bilateral Total Knee Replacement
A Phase 4 study testing Hydrocortisone and Saline in people with Postoperative Inflammatory Response, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Postoperative Inflammatory Response
- What is being tested?
- Hydrocortisone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Feb 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for bilateral total knee replacement
- Between 50-90 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: 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.
Read more
Therefore the investigators hypothesize:
Continued low dose steroids given three times over a 24 hour period will:
- Significantly decrease peak IL6 cytokine release during bilateral total knee replacement and maintaining this reduction in IL6 beyond 24 hours.
- Decrease urinary desmosine levels, and hence be protective of lung injury.
- Conditions
- Postoperative Inflammatory Response
- Being tested
- Hydrocortisone, Saline
- Keywords
- Bilateral total knee replacement, cytokine, desmosine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times
SalineDrug
Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
| Study group | Role | What they receive |
|---|---|---|
| Steroid | Experimental | Hydrocortisone 100 mg IV Q 8hrs x3 Receives: Drug: Hydrocortisone |
| Control | Placebo comparator | Saline IV Q8hr x3 Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in IL6 Level
Measured: 24 hours postoperative
Secondary outcomes (6)
Desmosine Level
Measured: 24 hours postoperative
Blood Glucose
Measured: 24 hours postoperative
Length of Hospital Stay
Measured: Length of hospital stay, an expected average of 5 days
In Hospital Infection Rate
Measured: Length of hospital stay, an expected average of 5 days
Mortality
Measured: Length of hospital stay, an expected average of 5 days
Ability to Ambulate
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startFeb 2009
- Primary completionAug 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kethy Jules-Elysee, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399268
- Sponsor's protocol ID
- HSS-28116
- Status last verified
- Jul 2017
- First submitted
- 14 Jul 2011
- Last updated
- 31 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 35087332
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Steroids Given Over 24 Hours on Cytokine Release and Urinary Desmosine Levels in Patients Undergoing Bilateral Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01399268
- Acronym / sponsor ID
- HSS-28116
- Conditions
- Postoperative Inflammatory Response
- Keywords
- Bilateral total knee replacement, cytokine, desmosine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Posted 31 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Significantly decrease peak IL6 cytokine release during bilateral total knee replacement and maintaining this reduction in IL6 beyond 24 hours.
- Decrease urinary desmosine levels, and hence be protective of lung injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid | Experimental | Drug: HydrocortisoneHydrocortisone 100 mg IV Q 8hrs x3 |
| Control | Placebo comparator | Drug: SalineSaline IV Q8hr x3 |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for bilateral total knee replacement
- Between 50-90 years of age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisonePrepared by pharmacy, 100 mg, IV, every 8 hours, 3 times | Drug | Steroid |
| SalinePrepared by pharmacy same volume as study drug, IV, every 8 hours 3 times | Drug | Control |
Primary outcome
Decrease in IL6 Level
Time frame: 24 hours postoperative
6 secondary outcomes
Desmosine Level
Time frame: 24 hours postoperative
Blood Glucose
Time frame: 24 hours postoperative
Length of Hospital Stay
Time frame: 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
Mortality
Time frame: Length of hospital stay, an expected average of 5 days
Ability to Ambulate
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35087332McLawhorn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kethy Jules-Elysee, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone and Saline in people with Postoperative Inflammatory Response, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in IL6 Level (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01399268, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.