Septic Shock
Conditions
Keywords
septic shock, hydrocortisone, mortality
Brief summary
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.
Interventions
DRUGHydrocortisone
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).
DRUGsaline
Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
Sponsors
Northern Jiangsu People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age 18 years old or older; 2. onset of septic shock within 6 h
Exclusion criteria
1. Systemic corticosteroid therapy within the last 3 months before septic shock; 2. high-dose steroid therapy; 3. immunosuppression; 4. refusal of the attending staff or patient family.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day Mortality | 28 days | Death from any cause at 28 days after the onset of septic shock |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality | 90 days | Death from any cause at 90 days after the onset of septic shock |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. | 60 |
| 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). | 58 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo | Hydrocortisone | Total |
|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 16.7 | 68.8 years STANDARD_DEVIATION 12.6 | 66.77 years STANDARD_DEVIATION 14.9 |
| Region of Enrollment China | 60 participants | 58 participants | 118 participants |
| Sex: Female, Male Female | 23 Participants | 25 Participants | 48 Participants |
| Sex: Female, Male Male | 37 Participants | 33 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 19 / 60 | 23 / 58 |
| other Total, other adverse events | 2 / 60 | 1 / 58 |
| serious Total, serious adverse events | 0 / 60 | 1 / 58 |
Outcome results
Primary
28-day Mortality
Death from any cause at 28 days after the onset of septic shock
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | 28-day Mortality | 19 Participants |
| Hydrocortisone | 28-day Mortality | 23 Participants |
Secondary
All Cause Mortality
Death from any cause at 90 days after the onset of septic shock
Time frame: 90 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | All Cause Mortality | 19 Participants |
| Hydrocortisone | All Cause Mortality | 23 Participants |