Health Trials

Early Intravenous Hydrocortisone in Sepsis

ConditionsSepsis SevereShock, Septic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSiriraj Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Early hydrocortisone
  • Normal saline placebo
  • Open-label hydrocortisone

Treatment groups

230 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting10700, Bangkoknoi, BangkokThailandThailand

Sponsors and collaborators

Siriraj Hospital

Lead sponsor

Source ClinicalTrials.gov