ADjunctive coRticosteroid trEatment iN criticAlly ilL Patients With Septic Shock

• Status: Completed
• Trial end date: 2017-11-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out whether adult patients admitted to the Intensive Care Unit with septic shock who are given hydrocortisone compared to placebo (a dummy solution), will have an improved rate of survival 90 days later.

Septic shock is the result of an infection, which triggers a complex response by the body (the inflammatory response) that causes a decrease in blood pressure and subsequently one or more organ systems to fail when blood supply to these organs is reduced. This may result in poor recovery and death. About a quarter of the people who suffer septic shock that is not rapidly reversed, will die.

When patients are admitted to Intensive Care with sepsis and/or septic shock they receive a number of therapies. These include fluids given through a drip, antibiotics, drugs to boost your blood pressure and other organ systems.

In addition to these therapies, steroids (hydrocortisone) are sometimes administered. Whether steroids are useful or not in the treatment of severe infections has been studied for more than 50 years. Previous research has suggested that the use of low dose steroid may have shortterm benefits in improving the circulation. However, there is no agreement amongst doctors around the world about whether treatment with or without low dose steroids improves the overall recovery and survival in patients with septic shock. This study would allow doctors to make informed decisions about whether the addition of low dose steroid therapy is better for patients with septic shock in intensive care.

The study will include 3800 intensive care patients who have septic shock. Each enrolled patient will be randomised to receive either Hydrocortisone 200mg or placebo daily for 7 days as a continuous intravenous infusion while in intensive care. The patient will be followed for 90 days. If the patient is discharged prior to 90 days a telephone call will be made for the followup information. At six months the patient will be contacted again for completion of a quality of life questionnaire.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Institute
• Collaborators: Australian and New Zealand Intensive Care Society Clinical Trials Group; National Health and Medical Research Council, Australia
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

Criteria

Inclusion Criteria:

1. Aged 18 years or older

2. Documented site of infection, or strong suspicion of infection, with 2 of the 4 clinical signs of inflammation:

• Core temperature > 38°C or < 35°C

• Heart rate > 90 beats per minute

• White cell count > 12 x 109/L or < 4 x 109/L or > 10% immature neutrophils

• Respiratory rate > 20 breaths per minute, or PaCO2 < 32 mmHg, or mechanical ventilation.

3. Being treated with mechanical ventilation at the time of randomisation

4. 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

5. Administration of vasopressors or inotropes for = 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.