Acute Lung Injury, Acute Respiratory Distress Syndrome, Septic Shock, Severe Sepsis
Conditions
Keywords
Septic shock, Severe sepsis, Acute lung injury, Acute respiratory distress syndrome, ARDS
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.
Interventions
DRUGPlacebo
Normal saline 50 ml intravenous every 6 hours for 7 days
DRUGHydrocortisone
Hydrocortisone 50 mg intravenous every 6 hours for 7 days
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 28 days | Death from any cause at 28 days after diagnosis of severe sepsis/septic shock |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventilator free day | 28 day | Day of alive within 28 days without mechanical ventilator support. |
| Vasopressor free day | 28 days | Days of alive within 28 days without any doses of vasopressors including dopamine, norepinephrine, adrenaline or dobutamine. |
| Rate of renal replacement therapy | 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 | 28 days | Days of alive without ventilator, renal replacement therapy and vasopressors within 28 days after diagnosis of severe sepsis or septic shock. |
Countries
Thailand
Outcome results
None listed