Early Intravenous Hydrocortisone in Sepsis

NCT06217939 | Recruiting

• 1 other identifier: Si 917/2023
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis Severe; Shock, Septic

Keywords

sepsis; hydrocortisone; shock; early

Outcome Measures

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.

  From randomization to 28 days after randomization

Secondary Outcomes (12)

• Time to shock control

  From randomization to shock control, assessed up to 28 days

• In-hospital mortality

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

• Hospital length of stay

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

• Ventilator-free day

  From randomization to 28 days after randomization

• Vasopressor-free day

  From randomization to 28 days after randomization

Study Arms (2)

Early hydrocortisone

EXPERIMENTAL

After randomization, low-dose hydrocortisone will be administered as soon as possible

Drug: Early hydrocortisone; Drug: Open-label hydrocortisone

Standard care

PLACEBO COMPARATOR

Low-dose hydrocortisone will be given when indicated according to the current Surviving Sepsis Campaign Guidelines

Drug: Normal saline placebo; Drug: Open-label hydrocortisone

Interventions

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.

Standard care

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.

Early hydrocortisone; Standard care

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.

Early hydrocortisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Sepsis; Shock, Septic; Shock

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chairat Permpikul, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wasin Pansiritanachot, MD

CONTACT

66896808508; dr.wasinpan@gmail.com

Chairat Permpikul, MD

CONTACT

+66 81-408-1676; chairat.per@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 23, 2024
• Study Start: June 25, 2024
• Primary Completion: June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 3 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal

Locations

TH (1)