Predictors for Responsiveness to Corticosteroid in Patients With Early Acute Respiratory Distress Syndrome

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Gee Young Suh, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01093287
First received: March 24, 2010
Last updated: June 10, 2012
Last verified: June 2012
  Purpose

In a recent multicenter randomized controlled trial, prolonged administration of low-dose methylprednisolone (1mg/kg/day) initiated in early acute respiratory distress syndrome was associated with earlier resolution of pulmonary and extrapulmonary organ dysfunction and reduction in duration of mechanical ventilation and intensive care unit stay. However, glucocorticoids may induce serious adverse events and these adverse events might compensate the positive effect of prolonged methylprednisolone infusion and discourage physicians from treating acute respiratory distress syndrome patients with glucocorticoids. Early prediction of responsiveness to prolonged methylprednisolone infusion would be help to decide whether to continue or not prolonged methylprednisolone infusion and this could reduce the drug related adverse events. We project to evaluate the predictors of responsiveness to prolonged methylprednisolone infusion in early acute respiratory distress syndrome .


Condition
Acute Respiratory Distress Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Predictors for Responsiveness to Corticosteroid in Patients With Early Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All patients meeting the American European Consensus definition of acute respiratory distress syndrome will be included, regardless of etiology of respiratory failure.

Criteria

Inclusion Criteria:

  • AECC definition of acute respiratory distress syndrome
  • Early acute respiratory distress syndrome (within 72 h of diagnosis)
  • PF ratio < 200 at PEEP ≥ 8 cmH2O

Exclusion Criteria:

  • Imminent death
  • Contraindication to corticosteroid treatment
  • Already on more than 0.5 mg/kg of methylprednisolone or its equivalent
  • Evidence of uncontrolled infection
  • Refusal of managing physician to participate in the study
  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: NCT01093287

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Gee Young Suh, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01093287     History of Changes
Other Study ID Numbers: 2009-08-075
Study First Received: March 24, 2010
Last Updated: June 10, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on October 01, 2014