Efficacy of Hydrocortisone in Treatment of Severe Sepsis/Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)

• All cause mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  Death from any cause at 28 days after diagnosis of severe sepsis/septic shock
  
  

• Ventilator free day [ Time Frame: 28 day ] [ Designated as safety issue: No ]
  Day of alive within 28 days without mechanical ventilator support.
  
  
• Vasopressor free day [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  Days of alive within 28 days without any doses of vasopressors including dopamine, norepinephrine, adrenaline or dobutamine.
  
  
• Rate of renal replacement therapy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  Proportion of the patients who received renal replacement therapy within 28 days after diagnosis of severe sepsis or septic shock.
  
  
• Organ support free days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  Days of alive without ventilator, renal replacement therapy and vasopressors within 28 days after diagnosis of severe sepsis or septic shock.
  
  

Severe sepsis/septic shock is a serious condition associated with high mortality rate. The pathophysiology of the disease involves the complex interaction between host's immunity and the microorganisms toxin. The release of immune complex and cascade of inflammatory cytokines are responsible for multiorgan dysfunction, especially the cardiovascular system. Hydrocortisone has been recommended as a useful treatment to decrease mortality in hemodynamically unstable septic shock patients, not response to fluid and moderate dose of vasopressor. Both anti-inflammation and supplementation of relatively adrenal insufficiency are the main hypothesis of the benefit of hydrocortisone. During the progression of severe sepsis/septic shock, multi-organ dysfunction can develop. Acute lung injury (ALI) and its more severe form, acute respiratory syndrome (ARDS) is one of the common organ dysfunction associated with septic shock. Although there is controversy about timing and favorable patients'characteristic, the information from a meta-analysis suggested that moderate dose of hydrocortisone may improve the ARDS patients' outcome. Whether hydrocortisone can effectively prevent disease progression and death in severe sepsis/septic shock patients who complicated with ALI/ARDS has not been proven.