An interventional study of Hydrocortisone and saline in Septic Shock, sponsored by Northern Jiangsu People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-07.
Sponsored by Northern Jiangsu People's Hospital · Not applicable, Interventional, and Treatment
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.
861 studies on the registry are indexed under Shock, Septic; 206 are open to participants now.
This study's enrollment of 118 is above the median of 79 across 529 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Northern Jiangsu People's Hospital is the lead sponsor of 60 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
Drug: saline
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).
Drug: 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).
Also known as: cortisol
Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
Also known as: Normal saline
28-day Mortality
Death from any cause at 28 days after the onset of septic shock
Time frame: 28 days
All Cause Mortality
Death from any cause at 90 days after the onset of septic shock
Time frame: 90 days
| Milestone | Placebo | Hydrocortisone |
|---|---|---|
| Started | 62 | 58 |
| Completed | 60 | 58 |
| Not completed | 2 | 0 |
| Withdrew: Physician decision | 2 | 0 |
Death from any cause at 28 days after the onset of septic shock
| Participants | Placebo | Hydrocortisone |
|---|---|---|
| 28-day Mortality | 19 | 23 |
Death from any cause at 90 days after the onset of septic shock
| Participants | Placebo | Hydrocortisone |
|---|---|---|
| All Cause Mortality | 19 | 23 |
Collected over 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.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 19/60 (31.7%) | 0/60 (0%) | 2/60 (3.3%) |
| Hydrocortisone | 23/58 (39.7%) | 1/58 (1.7%) | 1/58 (1.7%) |
| Event | Placebo | Hydrocortisone |
|---|---|---|
| hyperglycemiaEndocrine disorders | 0/60 | 1/58 |
| Event | Placebo | Hydrocortisone |
|---|---|---|
| muscle weaknessMusculoskeletal and connective tissue disorders | 2/60 | 1/58 |
| Age, Continuous(years) | Placebo | Hydrocortisone | Total |
|---|---|---|---|
| Mean | 64.8 ± 16.7 | 68.8 ± 12.6 | 66.77 ± 14.9 |
| Sex: Female, Male(Participants) | Placebo | Hydrocortisone | Total |
|---|---|---|---|
| Female | 23 | 25 | 48 |
| Male | 37 | 33 | 70 |
| Region of Enrollment(participants) | Placebo | Hydrocortisone | Total |
|---|---|---|---|
| China | 60 | 58 | 118 |
Plan to share: No
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Northern Jiangsu People's Hospital