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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01284452
First Posted: January 27, 2011
Last Update Posted: April 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Surat Tongyoo, Mahidol University
  Purpose
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.

Condition Intervention
Septic Shock Severe Sepsis Acute Lung Injury Acute Respiratory Distress Syndrome Drug: Placebo Drug: Hydrocortisone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Surat Tongyoo, Mahidol University:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 28 days ]
    Death from any cause at 28 days after diagnosis of severe sepsis/septic shock


Secondary Outcome Measures:
  • Ventilator free day [ Time Frame: 28 day ]
    Day of alive within 28 days without mechanical ventilator support.

  • Vasopressor free day [ Time Frame: 28 days ]
    Days of alive within 28 days without any doses of vasopressors including dopamine, norepinephrine, adrenaline or dobutamine.

  • Rate of renal replacement therapy [ Time Frame: 28 days ]
    Proportion of the patients who received renal replacement therapy within 28 days after diagnosis of severe sepsis or septic shock.

  • Organ support free days [ Time Frame: 28 days ]
    Days of alive without ventilator, renal replacement therapy and vasopressors within 28 days after diagnosis of severe sepsis or septic shock.


Enrollment: 197
Study Start Date: December 2010
Study Completion Date: March 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Normal saline 50 ml intravenous every 6 hours for 7 days
Drug: Placebo
Normal saline 50 ml intravenous every 6 hours for 7 days
Active Comparator: Hydrocortisone
Hydrocortisone 50 mg intravenous every 6 hours for 7 days
Drug: Hydrocortisone
Hydrocortisone 50 mg intravenous every 6 hours for 7 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284452


Locations
Thailand
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Surat Tongyoo, MD Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Surat Tongyoo, MD, Mahidol University
ClinicalTrials.gov Identifier: NCT01284452     History of Changes
Other Study ID Numbers: Si630/2010
First Submitted: January 18, 2011
First Posted: January 27, 2011
Last Update Posted: April 20, 2015
Last Verified: April 2015

Keywords provided by Surat Tongyoo, Mahidol University:
Septic shock
Severe sepsis
Acute lung injury
Acute respiratory distress syndrome
ARDS

Additional relevant MeSH terms:
Syndrome
Wounds and Injuries
Sepsis
Toxemia
Shock
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Shock, Septic
Acute Lung Injury
Lung Injury
Disease
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents