Trial Outcomes & Findings for Initiation of Hydrocortisone for the Treatment of Septic Shock (NCT NCT02580240)

NCT ID: NCT02580240

Last Updated: 2017-08-07

Results Overview

Death from any cause at 28 days after the onset of septic shock

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 118 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2017-08-07

Participant Flow

Participant milestones

Measure	Placebo Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.	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).
Overall Study STARTED	62	58
Overall Study COMPLETED	60	58
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Placebo Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.	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).
Overall Study Physician Decision	2	0

Baseline Characteristics

Initiation of Hydrocortisone for the Treatment of Septic Shock

Baseline characteristics by cohort

Measure	Placebo n=60 Participants Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.	Hydrocortisone n=58 Participants 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).	Total n=118 Participants Total of all reporting groups
Age, Continuous	64.8 years STANDARD_DEVIATION 16.7 • n=5 Participants	68.8 years STANDARD_DEVIATION 12.6 • n=7 Participants	66.77 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	33 Participants n=7 Participants	70 Participants n=5 Participants
Region of Enrollment China	60 participants n=5 Participants	58 participants n=7 Participants	118 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Death from any cause at 28 days after the onset of septic shock

Outcome measures

Measure	Placebo n=60 Participants Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. saline: Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.	Hydrocortisone n=58 Participants 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). 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).
28-day Mortality	19 Participants	23 Participants

SECONDARY outcome

Timeframe: 90 days

Death from any cause at 90 days after the onset of septic shock

Outcome measures

Measure	Placebo n=60 Participants Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar. saline: Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.	Hydrocortisone n=58 Participants 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). 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).
All Cause Mortality	19 Participants	23 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 19 deaths

Hydrocortisone

Serious events: 1 serious events

Other events: 1 other events

Deaths: 23 deaths

Serious adverse events

Measure	Placebo n=60 participants at risk Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.	Hydrocortisone n=58 participants at risk 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).
Endocrine disorders hyperglycemia	0.00% 0/60 • 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.	1.7% 1/58 • 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.

Other adverse events

Measure	Placebo n=60 participants at risk Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.	Hydrocortisone n=58 participants at risk 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).
Musculoskeletal and connective tissue disorders muscle weakness	3.3% 2/60 • 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.	1.7% 1/58 • 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.

Additional Information

QQLv

Subei People's Hospital

Phone: 18051063899

Email: bonhomie2014@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place