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

Primary Purpose

Septic Shock, Severe Sepsis, Acute Lung Injury

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Placebo
Hydrocortisone
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Septic shock, Severe sepsis, Acute lung injury, Acute respiratory distress syndrome, ARDS

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Hydrocortisone

Arm Description

Normal saline 50 ml intravenous every 6 hours for 7 days

Hydrocortisone 50 mg intravenous every 6 hours for 7 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ventilator free day
Day of alive within 28 days without mechanical ventilator support.
Vasopressor free day
Days of alive within 28 days without any doses of vasopressors including dopamine, norepinephrine, adrenaline or dobutamine.
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.
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.

Full Information

First Posted
January 18, 2011
Last Updated
April 17, 2015
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01284452
Brief Title
Efficacy of Hydrocortisone in Treatment of Severe Sepsis/Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Severe Sepsis, Acute Lung Injury, Acute Respiratory Distress Syndrome
Keywords
Septic shock, Severe sepsis, Acute lung injury, Acute respiratory distress syndrome, ARDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline 50 ml intravenous every 6 hours for 7 days
Arm Title
Hydrocortisone
Arm Type
Active Comparator
Arm Description
Hydrocortisone 50 mg intravenous every 6 hours for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline 50 ml intravenous every 6 hours for 7 days
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
Hydrocortisone 50 mg intravenous every 6 hours for 7 days
Primary Outcome Measure Information:
Title
All cause mortality
Description
Death from any cause at 28 days after diagnosis of severe sepsis/septic shock
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Ventilator free day
Description
Day of alive within 28 days without mechanical ventilator support.
Time Frame
28 day
Title
Vasopressor free day
Description
Days of alive within 28 days without any doses of vasopressors including dopamine, norepinephrine, adrenaline or dobutamine.
Time Frame
28 days
Title
Rate of renal replacement therapy
Description
Proportion of the patients who received renal replacement therapy within 28 days after diagnosis of severe sepsis or septic shock.
Time Frame
28 days
Title
Organ support free days
Description
Days of alive without ventilator, renal replacement therapy and vasopressors within 28 days after diagnosis of severe sepsis or septic shock.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surat Tongyoo, MD
Organizational Affiliation
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
27741949
Citation
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.
Results Reference
derived

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

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