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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The major goal of this project is to determine whether the use of physiologic doses of corticosteroids will decrease time to shock reversal, alters the inflammatory cascade, and alters microcirculatory flow in post-cardiac arrest patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | Normal Saline |
|
| 1 | Experimental | Hydrocortisone 100mg every 8 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Saline | Drug | Normal Saline |
| |
| Hydrocortisone |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Shock Reversal | The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications. | 7 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Length of hospital stay, an average of 9 days with a maximum of 36 days | |
| Sub-group Analysis of Patients With Adrenal Insufficiency | Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level < 15 ug/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael W Donnino, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27038920 | Derived | Donnino MW, Andersen LW, Berg KM, Chase M, Sherwin R, Smithline H, Carney E, Ngo L, Patel PV, Liu X, Cutlip D, Zimetbaum P, Cocchi MN; Collaborating Authors from the Beth Israel Deaconess Medical Center's Center for Resuscitation Science Research Group. Corticosteroid therapy in refractory shock following cardiac arrest: a randomized, double-blind, placebo-controlled, trial. Crit Care. 2016 Apr 3;20:82. doi: 10.1186/s13054-016-1257-x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Normal Saline |
| FG001 | Intervention | Hydrocortisone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Normal Saline |
| BG001 | Intervention | Hydrocortisone |
| BG002 |
| 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 | Time to Shock Reversal | The primary outcome was time to shock reversal defined as at least 24 hours off all vasopressor medications. | Posted | Median | Inter-Quartile Range | hours | 7 Days |
|
|
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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 | Control | Normal Saline |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New or Changed Antibiotics | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Donnino | Beth Israel Deaconess Medical Center | mdonnino@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D012769 | Shock |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Drug |
Hydrocortisone 100mg |
|
| At time of enrollment |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Mortality | Posted | Count of Participants | Participants | Length of hospital stay, an average of 9 days with a maximum of 36 days |
|
|
|
| Secondary | Sub-group Analysis of Patients With Adrenal Insufficiency | Sub-analysis of patients with adrenal insufficiency: absolute insufficiency as defined by a baseline cortisol level < 15 ug/dL | There were 9 patients identified with baseline absolute cortisol deficiency (3 in the control arm and 6 in the intervention arm). This sub population of study participants were analyzed for shock reversal, good neurological outcomes, and survival as shown in each row of the table below. | Posted | Count of Participants | Participants | At time of enrollment |
|
|
|
| 16 |
| 25 |
| 19 |
| 25 |
| EG001 | Intervention | Hydrocortisone | 18 | 25 | 21 | 25 |
| New insulin infusion | Endocrine disorders |
|
| Any Bleeding | General disorders |
|
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| D011282 |
| Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | 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 |
| Survival in Adrenal Insufficient |
|