Efficacy of Hydrocortisone in Treatment of Severe Sepsis/Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Condition: Septic Shock; Severe Sepsis; Acute Lung Injury; Acute Respiratory Distress Syndrome
MeSH terms: Sepsis; Toxemia; Shock, Septic; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury; Syndrome; Shock; Wounds and Injuries
Study type: Interventional

Summary: 
      Severe sepsis/septic shock is a serious condition associated with high mortality rate.
      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. 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. 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.
    

Detailed description: 
      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.
    

Intervention name(s): Placebo; Hydrocortisone
Intervention type(s): Drug; Drug
Intervention description(s): Normal saline 50 ml intravenous every 6 hours for 7 days; Hydrocortisone 50 mg intravenous every 6 hours for 7 days
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Septic shock; Severe sepsis; Acute lung injury; Acute respiratory distress syndrome; ARDS