Trial Outcomes & Findings for Hemodynamic and Inflammatory Effects of Abrupt Versus Tapered Corticosteroid Discontinuation in Septic Shock (NCT NCT01150409)

Results Overview

Study screening/enrollment stopped due to lack of eligible subjects. No outcome measures were analyzed due to the low enrollment.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Day 14

Results posted on

2018-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Hydrocortisone Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days) hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days) Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)	Normal Saline (Placebo) 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days) Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)
Overall Study STARTED	11	0
Overall Study COMPLETED	11	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hemodynamic and Inflammatory Effects of Abrupt Versus Tapered Corticosteroid Discontinuation in Septic Shock

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydrocortisone n=11 Participants Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days) hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days) Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)	Normal Saline (Placebo) 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days) Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	—	9 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	—	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	—	6 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	—	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 14

Study screening/enrollment stopped due to lack of eligible subjects. No outcome measures were analyzed due to the low enrollment.

Outcome measures

Outcome data not reported

Adverse Events

Hydrocortisone

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline (Placebo)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Hydrocortisone n=11 participants at risk Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days) hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days) Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)	Normal Saline (Placebo) 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days) Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)
General disorders Septic Shock/Multi System Organ Failure	18.2% 2/11 • Number of events 2	— 0/0
General disorders Septic Shock/Poor Prognosis/Family Reuest to Withdraw Support	18.2% 2/11 • Number of events 2	— 0/0
Gastrointestinal disorders End Stage Liver Disease	27.3% 3/11 • Number of events 3	— 0/0
General disorders Respiratory Failure	9.1% 1/11 • Number of events 1	— 0/0
General disorders ARDS/H1N1	9.1% 1/11 • Number of events 1	— 0/0

Other adverse events

Adverse event data not reported

Additional Information

Jorge Guzman MD

The Cleveland Clinic Foundation

Phone: 216-445-5765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place