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

Condition(s) targeted: Septic Shock; Severe Sepsis; Acute Lung Injury; Acute Respiratory Distress Syndrome

Intervention: Placebo (Drug); Hydrocortisone (Drug)

Phase: N/A

Status: Completed

Sponsored by: Mahidol University

Official(s) and/or principal investigator(s):
Surat Tongyoo, MD, Principal Investigator, Affiliation: Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

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.

Official title: Efficacy of Moderate Dose Hydrocortisone in Treatment of Severe Sepsis and Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome: A Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: All cause mortality

Secondary outcome:

Ventilator free day

Vasopressor free day

Rate of renal replacement therapy

Organ support free days

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age 18 years and older

- Diagnosis of severe sepsis or septic shock according to the American College of Chest

Physicians/Society of Critical Care Medicine Consensus Conference 1992

- Diagnosis of acute lung injury or acute respiratory distress syndrome according to

the American-European Consensus Conference on ARDS 1994

- Onset of organ dysfunction within 12 hours before enrollment

Exclusion Criteria:

- Indicated for receive corticosteroid

- Congestive heart failure

- Contra-indication for hydrocortisone: For example: allergy to hydrocortisone

- Pregnancy

- Not agree to sign the consent form

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand

Starting date: December 2010
Last updated: April 17, 2015