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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12611001042932
• Date of registration: 05/10/2011
• Prospective Registration: Yes
• Primary sponsor: The George Institute for Global Health
• Public title: A randomised blinded placebo controlled trial of hydrocortisone in critically ill patients with septic shock.
• Scientific title: A multi-centre, blinded, randomised, placebo controlled trial to determine whether hydrocortisone therapy reduces 90-day mortality in patients admitted to intensive Care with septic shock.
• Date of first enrolment: 13/06/2012
• Target sample size: 3800
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12611001042932.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Phase 4

Countries of recruitment

Australia, Denmark, New Zealand, Saudi Arabia, United Kingdom

Contacts

• Name: Prof Professor Balasubramanian Venkatesh

• Name: Prof Professor Balasubramanian Venkatesh

Key inclusion & exclusion criteria

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: i. Core temperature > 38 degrees C or < 35 degrees C ii. Heart rate > 90 beats per minute iii. White cell count > 12 x 109/L or < 4 x 109/L or > 10% immature neutrophils iv. Respiratory rate > 20 breaths per minute, or PaCO2 < 32 mmHg, or mechanical ventilation. 4. Being treated with mechanical ventilation at the time of randomisation 5. Being treated with 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 greater than or equal to 4 hours and present at time of randomisation.
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.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Septic shock;
Septic shock

Infection - Studies of infection and infectious agents

Intervention(s)

Hydrocortisone 200mg per day given intravenously as a continuous infusion for 7 days

Primary Outcome(s)

All cause mortality at 90 days after randomisation[90 days after randomisation]

Secondary Outcome(s)

Time to resolution of shock - defined as "the time taken to achieve a clinician prescribed mean arterial pressure (MAP) goal for >24 hours without vasopressors or inotropes.[MAP goal for >24 hours without vasopressors or inotropes. Up to 90 days after randomisation.]

Frequency and duration of mechanical ventilation[Up to 90 days after randomisation]

Duration of ICU stay[Up to 90 days after randomisation]

Quality of Life - EQ5D assessment at 6 months.[6 months.]

All-cause mortality at 28 days and 6 months after randomisation[28 days and 6 months after randomisation]

Development of bacteraemia between 2 and 14 days post randomisation[2 and 14 days post randomisation]

Bleeding requiring blood transfusions received in the ICU[Up to 90 days after randomisation]

Recurrence of shock - defined as a new episode of shock after reversal of the initial episode.[Up to90 days after randomisation]

Duration of renal replacement therapy[Up to 90 days after randomisation]

Duration of hospital stay[Up to 90 days after randomisation]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Australian National Health and Medical Research Council (NHMRC)

Health Research Council of New Zealand

Ethics review

Status: Approved
Approval date:
Contact:

Sydney South West Area Health Service Human Research Ethics Review Committee (RPAH Zone)