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Trial record 1 of 17 for:    ARDS and hydrocortisone
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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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ClinicalTrials.gov Identifier: NCT01284452
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : April 20, 2015
Sponsor:
Information provided by (Responsible Party):
Surat Tongyoo, Mahidol University

Tracking Information
First Submitted Date  ICMJE January 18, 2011
First Posted Date  ICMJE January 27, 2011
Last Update Posted Date April 20, 2015
Study Start Date  ICMJE December 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2011)
All cause mortality [ Time Frame: 28 days ]
Death from any cause at 28 days after diagnosis of severe sepsis/septic shock
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Hydrocortisone in Treatment of Severe Sepsis/Septic Shock Patients With Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS)
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Septic Shock
  • Severe Sepsis
  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome
Intervention  ICMJE
  • Drug: Placebo
    Normal saline 50 ml intravenous every 6 hours for 7 days
  • Drug: Hydrocortisone
    Hydrocortisone 50 mg intravenous every 6 hours for 7 days
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Normal saline 50 ml intravenous every 6 hours for 7 days
    Intervention: Drug: Placebo
  • Active Comparator: Hydrocortisone
    Hydrocortisone 50 mg intravenous every 6 hours for 7 days
    Intervention: Drug: Hydrocortisone
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2015)
197
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2011)
194
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01284452
Other Study ID Numbers  ICMJE Si630/2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Surat Tongyoo, Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Surat Tongyoo, MD Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
PRS Account Mahidol University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP