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

NCT01284452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2015-04-20

No results posted yet for this study

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.

Conditions

  • Septic Shock
  • Severe Sepsis
  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome

Interventions

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

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Surat Tongyoo, MD · Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • Thailand

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01284452 on ClinicalTrials.gov