Dexamethasone for Cardiac Surgery study

Rationale

Cardiac surgery is associated with a postoperative systemic inflammatory response syndrome, which may contribute to mortality, myocardial infarction and other major complications. The inflammatory response can be suppressed with high dose corticosteroids, typically an intraoperative intravenous injection of dexamethasone 1 mg/kg. The use of high dose corticosteroids, however, can have a multitude of unwanted side effects including
immunosuppression, poor wound healing, inadequate glucose control, fluid retention,
hypertension, electrolyte imbalances, higher lactate levels, and gastrointestinal blood loss. These side effects themselves could contribute to the rate of major complications. At present, there is no evidence from clinical trials whether steroids increase or decrease the risk of major perioperative complications. As a result, the use of steroids in heart surgery is highly controversial and varies greatly across the countries where heart surgery is performed.




Study Objective

To determine whether the proportion of patients with one or more major complications (mortality, myocardial infarction, stroke, renal failure and prolonged mechanical ventilation) in the first month after cardiac surgery, is reduced by intra-operative administration of dexamethasone. Secondary objectives include an evaluation of the impact of dexamethasone on major complications at 1 year follow-up.




Study Design

This is a large but simple multi-centre, double-blinded, randomized controlled trial of dexamethasone versus placebo in 4,500 adult patients undergoing cardiac surgery.




Eligibility

Patients are eligible if they are undergoing cardiac and are 18 years or older.




Study Drug Administration

Patients will be randomized to receive a single intravenous injection of dexamethasone 1 mg/kg, or a single intravenous injection of placebo, immediately after induction of anesthesia.
Trial medication (dexamethasone or placebo) is administered by the attending anesthetist. Patients and treating physicians are blinded for treatment allocation.




Follow-up

A limited set of data will be collected during the patient’s hospital stay. The occurrence of one or more major complications will be determined at the 30th day after surgery. There will also be a long term follow-up at 1 year.

A single, prophylactic dose of dexamethasone during cardiac surgery reduces the incidence of major postoperative complications.

1. 30 days (prim);

2. 1 year (sec).

Administration of dexamethasone 1 mg/kg, or placebo.