Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised Blinded Placebo Controlled Trial of Hydrocortisone in Critically Ill Patients With Septic Shock
Brief 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.


Options:
A: Arm Label: Hydrocortisone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydrocortisone | Arm Label: Sterile air filled vial; Type: PLACEBO_COMPARATOR; Interventions: Drug: Sterile air filled vial | Intervention Type: DRUG; Name: Hydrocortisone; Assigned to Arm(s): Hydrocortisone | Intervention Type: DRUG; Name: Sterile air filled vial; Assigned to Arm(s): Sterile air filled vial
B: Arm Label: Experimental Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: methylprednisolone | Arm Label: Placebo Group; Type: PLACEBO_COMPARATOR; Interventions: Drug: Normal Saline (0.9%) | Intervention Type: DRUG; Name: methylprednisolone; Assigned to Arm(s): Experimental Group | Intervention Type: DRUG; Name: Normal Saline (0.9%); Assigned to Arm(s): Placebo Group
C: Arm Label: H; Type: EXPERIMENTAL; Interventions: Drug: hydrocortisone | Arm Label: P; Type: PLACEBO_COMPARATOR; Interventions: Drug: NaCl | Intervention Type: DRUG; Name: hydrocortisone; Assigned to Arm(s): H | Intervention Type: DRUG; Name: NaCl; Assigned to Arm(s): P
D: Arm Label: Hydrocortisone and fludrocortisone; Type: EXPERIMENTAL; Interventions: Drug: Hydrocortisone Fludrocortisone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Controlled; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Hydrocortisone Fludrocortisone; Assigned to Arm(s): Hydrocortisone and fludrocortisone

Answer: A