A randomised blinded placebo controlled trial of hydrocortisone in critically ill patients with septic shock

Phase 1

• Conditions: Septic Shock; MedDRA version: 17.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-003158-10-IE
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 3800

Inclusion Criteria

1. Aged 18 years or older
2. Documented site of infection, or strong suspicion of infection
3. 2 of the 4 clinical signs of inflammation:
a. Core temperature > 38oC or < 36oC
b. Heart rate > 90 beats per minute
c. Respiratory rate > 20 breaths per minute, or PaCO2 < 32 mmHg, or mechanical ventilation.
d. White cell count > 12 x 109/L or < 4 x 109/L or > 10% immature neutrophils
4. Being treated with mechanical ventilation at the time of randomisation (includes BiPAP or CPAP)
5. Being treated with continuous vasopressors or inotropes to maintain a systolic blood pressure > 90mmHg, or mean arterial blood pressure > 60mmHg, or a MAP target set by the treating clinician for maintaining perfusion
6. Administration of vasopressors or inotropes for = 4 hours and present at time of randomisation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

Exclusion Criteria

1. Met all inclusion criteria more than 24 hours ago
2. Clinician expects to prescribe systemic corticosteroids for an indication other than septic shock (not including nebulised or inhaled corticosteroid)
3. Patients treated with etomidate
4. Patients receiving treatment with Amphotericin B for systemic fungal infections at time of randomisation
5. Patients with documented cerebral malaria at the time of randomisation
6. Patients with documented strongyloides infection at the time of randomisation
7. Death is deemed inevitable or imminent during this admission and either the attending physician, patient or surrogate legal decision maker is not committed to active treatment
8. Death from underlying disease is likely within 90 days
9. Patient has been previously enrolled in the ADRENAL study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified