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

NCT ID: NCT01284452

Last Updated: 2015-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-03-31

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.

Conditions

Septic Shock; Severe Sepsis; Acute Lung Injury; Acute Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Normal saline 50 ml intravenous every 6 hours for 7 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Normal saline 50 ml intravenous every 6 hours for 7 days

Hydrocortisone

Hydrocortisone 50 mg intravenous every 6 hours for 7 days

Group Type: ACTIVE_COMPARATOR

Hydrocortisone

Intervention Type: DRUG

Hydrocortisone 50 mg intravenous every 6 hours for 7 days

Interventions

Placebo

Normal saline 50 ml intravenous every 6 hours for 7 days

Intervention Type: DRUG

Hydrocortisone

Hydrocortisone 50 mg intravenous every 6 hours for 7 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Surat Tongyoo

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Surat Tongyoo, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Locations

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Countries

Thailand

References

Tongyoo S, Permpikul C, Mongkolpun W, Vattanavanit V, Udompanturak S, Kocak M, Meduri GU. Hydrocortisone treatment in early sepsis-associated acute respiratory distress syndrome: results of a randomized controlled trial. Crit Care. 2016 Oct 15;20(1):329. doi: 10.1186/s13054-016-1511-2.

Reference Type: DERIVED

PMID: 27741949 (View on PubMed)

Other Identifiers

Si630/2010

Identifier Type: -

Identifier Source: org_study_id