Trial record 3 of 404 for:    "Acute respiratory distress syndrome"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Surat Tongyoo, Mahidol University
ClinicalTrials.gov Identifier:
NCT01284452
First received: January 18, 2011
Last updated: May 1, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Mahidol University:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Death from any cause at 28 days after diagnosis of severe sepsis/septic shock


Secondary Outcome Measures:
  • Ventilator free day [ Time Frame: 28 day ] [ Designated as safety issue: No ]
    Day of alive within 28 days without mechanical ventilator support.

  • Vasopressor free day [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Days of alive without ventilator, renal replacement therapy and vasopressors within 28 days after diagnosis of severe sepsis or septic shock.


Estimated Enrollment: 194
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284452

Contacts
Contact: Surat Tongyoo, MD 6624198534 surat_Ty@yahoo.co.uk

Locations
Thailand
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Surat Tongyoo, MD    6624198534    surat_Ty@yahoo.co.uk   
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Surat Tongyoo, MD Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
  More Information

No publications provided

Responsible Party: Surat Tongyoo, MD, Mahidol University
ClinicalTrials.gov Identifier: NCT01284452     History of Changes
Other Study ID Numbers: Si630/2010
Study First Received: January 18, 2011
Last Updated: May 1, 2013
Health Authority: Thailand: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 21, 2014