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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Early hydrocortisone

    Drug

    For the Early Hydrocortisone group, 50 mg of hydrocortisone in 10 ml of normal saline will be given as an intravenous bolus, then 200 mg of hydrocortisone in 100 ml of normal saline will be given as continuous intravenous infusion in 24 hours for 2 consecutive days (total 250 mg in day 1 and 200 mg in day 2). After completion of the study drugs for 2 days, the study drug will be discontinued without tapering.

  • Normal saline placebo

    Drug

    For the Standard Care group, a bolus of 10 ml of normal saline will be given, then 100 ml of normal saline will be given as continuous intravenous infusion in 24 hours for 2 consecutive days as a sham control. After completion of the study drugs for 2 days, the study drug will be discontinued without tapering.

  • Open-label hydrocortisone

    Drug

    An open-label 50 mg of hydrocortisone given as an intravenous bolus followed by intravenous hydrocortisone 200 mg/day given as continuous infusion or divided bolus administration is suggested to be commenced in both study arms if the hemodynamic goal of the patient is not reached despite the dose of norepinephrine or epinephrine ≥ 0.25 mcg/kg/min at least 4 hours after the initiation of the vasopressors as recommended by the guideline. The study drug in each arm will be discontinued once an open-label hydrocortisone is initiated. Capillary or venous blood glucose will be tested at least every 6 hours for 2 days then at least once daily or more as appropriate for the first 7 days as a part of the study protocol.

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: Early hydrocortisoneExperimental treatment 2 interventions
Group B: Standard carePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

28-day mortality

Death within 28 days after randomization. Patients who are discharged alive before 28 days are considered to have no 28-day mortality.

Time frame
From randomization to 28 days after randomization

Secondary outcomes

1

Time to shock control

Shock control is defined as achievement of sustained mean arterial pressure ≥ 65 mm Hg or higher for at least 30 minutes together with evidence of adequate tissue perfusion (urine flow at more than 0.5 ml/kg/h for 2 consecutive hours, or decreased in serum lactate by more than 10% from the initial lactate level)

Time frame
From randomization to shock control, assessed up to 28 days
2

In-hospital mortality

Death during the current hospitalization

Time frame
From randomization to the end of hospitalization, assessed up to 3 months
3

Hospital length of stay

Days from randomization to hospital discharge or death

Time frame
From randomization to hospital discharge or death, assessed up to 3 months
4

Ventilator-free day

Ventilator-free day is defined as the number of days that patients were alive and free of ventilators up to day 28. Patients who die before day 28 will be assigned zero free day.

Time frame
From randomization to 28 days after randomization

Other outcomes

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 contacts

Click on the lead sponsor to view all of their trials.

Siriraj Hospital

Lead sponsor

Source ClinicalTrials.gov
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