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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid | Experimental | Hydrocortisone 100 mg IV Q 8hrs x3 |
|
| Control | Placebo Comparator | Saline IV Q8hr x3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone | Drug | Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in IL6 Level | 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Desmosine Level | 24 hours postoperative | |
| Blood Glucose | 24 hours postoperative | |
| Length of Hospital Stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kethy Jules-Elysee, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35087332 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Steroid | Hydrocortisone 100 mg IV Q 8hrs x3 Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times |
| FG001 | Control | Saline IV Q8hr x3 Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Steroid | Hydrocortisone 100 mg IV Q 8hrs x3 Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times |
| BG001 | Control | Saline IV Q8hr x3 Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decrease in IL6 Level | Posted | Mean | 99% Confidence Interval | pg/ml | 24 hours postoperative |
|
|
The study collected data for 30 days after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Steroid | Hydrocortisone 100 mg IV Q 8hrs x3 Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jules | HSS | 212.606.1206 | JulesK@hss.edu |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Saline |
| Drug |
Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times |
|
| 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 |
| Ability to Ambulate | 48 hours |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Desmosine Level | Data were not collected | Posted | 24 hours postoperative |
|
|
|
| Secondary | Blood Glucose | Posted | Mean | Standard Deviation | mg/dL | 24 hours postoperative |
|
|
|
| Secondary | Length of Hospital Stay | Posted | Mean | Standard Deviation | days | Length of hospital stay, an expected average of 5 days |
|
|
|
| Secondary | In Hospital Infection Rate | Posted | Count of Participants | Participants | Length of hospital stay, an expected average of 5 days |
|
|
|
| Secondary | Mortality | Posted | Count of Participants | Participants | Length of hospital stay, an expected average of 5 days |
|
|
|
| Secondary | Ability to Ambulate | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Control | Saline IV Q8hr x3 Saline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times | 0 | 15 | 0 | 15 | 0 | 15 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |