Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
230 (estimated)
Sponsor
Siriraj Hospital · Other
Who this trial is looking for
This trial is looking for adults who have severe infections and low blood pressure. Participants will either receive early steroid treatment or a placebo to see which is more effective.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have suspected or definite sepsis.
I have low blood pressure with mean arterial pressure less than 65 mmHg.
You may not be able to join if
I cannot start treatment within 3 hours after my low blood pressure starts.
I have a type of shock that isn't caused by sepsis.
I am immunocompromised.
I have a hyperglycemic crisis.
I am pregnant.
I have recently had a cardiac arrest.
I have received etomidate before this trial.
I have taken systemic corticosteroids within the last 4 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The goal of this clinical trial is to compare two timings of steroid treatment in patients with severe infection who develop low blood pressure.
The main question it aims to answer is:
• Which timing strategy is better between starting steroid treatment very early in the course of severe infection, or waiting until the patient does not respond to medicine that raises blood pressure according to …
The goal of this clinical trial is to compare two timings of steroid treatment in patients with severe infection who develop low blood pressure.
The main question it aims to answer is:
• Which timing strategy is better between starting steroid treatment very early in the course of severe infection, or waiting until the patient does not respond to medicine that raises blood pressure according to the current guidelines?
Participants will receive either early steroid treatment or placebo right after they develop low blood pressure from infection. Both participants and treating doctors will not know which treatment participants received. When blood pressure goal is not reached after a moderate dose of drugs that raise blood pressure, an open-label steroid treatment will be given to participants as indicated in the current guidelines.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* Age of 18 years or older
* Suspected or definite sepsis Sepsis is defined by SEPSIS-3 definition as Sequential Organ Failure Assessment (SOFA) score ≥ 2 from baseline with suspected infection.2 Suspected sepsis is defined as patients with suspected infection who meet 2 or more…
Inclusion Criteria:
* Age of 18 years or older
* Suspected or definite sepsis Sepsis is defined by SEPSIS-3 definition as Sequential Organ Failure Assessment (SOFA) score ≥ 2 from baseline with suspected infection.2 Suspected sepsis is defined as patients with suspected infection who meet 2 or more criteria of quick SOFA (altered mentation, respiratory rate ≥ 22/min, systolic blood pressure ≤ 100 mmHg).
* Hypotension (mean arterial pressure \< 65 mmHg)
Exclusion Criteria:
* Randomization and administration of the study drugs are not able to be executed within 3 hours after the onset of hypotension
* Causes of shock other than sepsis identified
* Immunocompromised A patient is considered immunocompromised if one of the following criteria is met: history of human immunodeficiency virus infection or acquired immunodeficiency syndrome, hematologic malignancy, receiving chemotherapy, active cancer receiving chemotherapy, current use of immunosuppressive medication)
* Hyperglycemic crisis (diabetic ketoacidosis, hyperosmolar hyperglycemic state)
* Pregnancy
* Post-cardiac arrest
* Received etomidate before randomization
* Systemic corticosteroids indicated for other conditions
* Received systemic corticosteroids within 4 weeks at any dose
* Cancer patients who are receiving palliative treatment
* Do-not-resuscitate order
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