Initiation of Hydrocortisone for the Treatment of Septic Shock

Northern Jiangsu People's Hospital

Status: Completed

Conditions: Septic Shock

Treatments: Drug: Hydrocortisone; Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02580240

2015KY-127

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

118 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.

Treatment:

Drug: saline

hydrocortisone

Experimental group

Description:

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).

Treatment:

Drug: Hydrocortisone