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The purpose of this study : 1）to determine whether hydrocortisone is effective in the treatment of septic shock and 2) to identify the role of timing of low dose hydrocortisone administration in septic shock patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. |
|
| hydrocortisone | Experimental | Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone | Drug | Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped). |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day Mortality | Death from any cause at 28 days after the onset of septic shock | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality | Death from any cause at 90 days after the onset of septic shock | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qingquan Lv, Master | Department of Critical Care Medicine, Northern Jiangsu Province people's hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern Jiangsu Province people's hospital | Yangzhou | Jiangsu | 225000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28615145 | Derived | Lv QQ, Gu XH, Chen QH, Yu JQ, Zheng RQ. Early initiation of low-dose hydrocortisone treatment for septic shock in adults: A randomized clinical trial. Am J Emerg Med. 2017 Dec;35(12):1810-1814. doi: 10.1016/j.ajem.2017.06.004. Epub 2017 Jun 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. |
| FG001 | Hydrocortisone | Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. |
| BG001 | Hydrocortisone | Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped). |
| 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 | 28-day Mortality | Death from any cause at 28 days after the onset of septic shock | Posted | Count of Participants | Participants | 28 days |
|
Adverse Events were classified by onset time （within 60 days after the onset of septic shock）.The adverse events were assessed from date of randomization until 60 days after the onset of septic shock or date of death from any cause, whichever came first, assessed up to 60 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 | Placebo | Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyperglycemia | Endocrine disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| muscle weakness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| QQLv | Subei People's Hospital | 18051063899 | bonhomie2014@163.com |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| saline | Drug | Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | All Cause Mortality | Death from any cause at 90 days after the onset of septic shock | Posted | Count of Participants | Participants | 90 days |
|
|
|
| 19 |
| 60 |
| 0 |
| 60 |
| 2 |
| 60 |
| EG001 | Hydrocortisone | Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped). | 23 | 58 | 1 | 58 | 1 | 58 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| 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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |