Early Intravenous Hydrocortisone in Sepsis: a Randomized Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
RECRUITING
Bangkoknoi
Contact Information
Primary
Wasin Pansiritanachot, MD
dr.wasinpan@gmail.com
66896808508
Backup
Chairat Permpikul, MD
chairat.per@mahidol.ac.th
+66 81-408-1676
Time Frame
Start Date: 2024-06-25
Estimated Completion Date: 2026-09
Participants
Target number of participants: 230
Treatments
Experimental: Early hydrocortisone
After randomization, low-dose hydrocortisone will be administered as soon as possible
Placebo_comparator: Standard care
Low-dose hydrocortisone will be given when indicated according to the current Surviving Sepsis Campaign Guidelines
Related Therapeutic Areas
Sponsors
Leads: Siriraj Hospital

This content was sourced from clinicaltrials.gov