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

Septic Shock Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284452
• Other study ID #: Si630/2010
• Status: Completed
• Phase: N/A
• First received: January 18, 2011
• Last updated: April 17, 2015
• Start date: December 2010
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: March 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Sepsis
• Septic Shock
• Severe Sepsis
• Shock
• Shock, Septic
• Syndrome
• Toxemia

Intervention

Drug:
• Placebo
Normal saline 50 ml intravenous every 6 hours for 7 days
• Hydrocortisone
Hydrocortisone 50 mg intravenous every 6 hours for 7 days

Locations

Country	Name	City	State
Thailand	Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Death from any cause at 28 days after diagnosis of severe sepsis/septic shock	28 days	No
Secondary	Ventilator free day	Day of alive within 28 days without mechanical ventilator support.	28 day	No
Secondary	Vasopressor free day	Days of alive within 28 days without any doses of vasopressors including dopamine, norepinephrine, adrenaline or dobutamine.	28 days	Yes
Secondary	Rate of renal replacement therapy	Proportion of the patients who received renal replacement therapy within 28 days after diagnosis of severe sepsis or septic shock.	28 days	Yes
Secondary	Organ support free days	Days of alive without ventilator, renal replacement therapy and vasopressors within 28 days after diagnosis of severe sepsis or septic shock.	28 days	Yes