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

Not Applicable

Completed

• Conditions: Septic Shock; Severe Sepsis; Acute Respiratory Distress Syndrome; Acute Lung Injury
• Interventions: Drug: Placebo; Drug: Hydrocortisone

• Registration Number: NCT01284452
• Lead Sponsor: Mahidol University

Brief 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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Normal saline 50 ml intravenous every 6 hours for 7 days
Hydrocortisone	Hydrocortisone	Hydrocortisone 50 mg intravenous every 6 hours for 7 days

Primary Outcome Measures

Name	Time	Method
All cause mortality	28 days	Death from any cause at 28 days after diagnosis of severe sepsis/septic shock

Secondary Outcome Measures

Name	Time	Method
Organ support free days	28 days	Days of alive without ventilator, renal replacement therapy and vasopressors within 28 days after diagnosis of severe sepsis or septic shock.
Ventilator free day	28 day	Day of alive within 28 days without mechanical ventilator support.
Vasopressor free day	28 days	Days of alive within 28 days without any doses of vasopressors including dopamine, norepinephrine, adrenaline or dobutamine.
Rate of renal replacement therapy	28 days	Proportion of the patients who received renal replacement therapy within 28 days after diagnosis of severe sepsis or septic shock.

Trial Locations

Locations (1)

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand