Comparing early and conventional stopping of hydrocortisone in septic shock treatment
Composite Adverse Events Compared Early Versus Conventional Cessation of Hydrocortisone in Patients With Septic Shock: Randomized-controlled Trial
This study is testing whether stopping hydrocortisone early or later helps patients with septic shock recover better and have fewer side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok) |
| Trial ID | NCT05818826 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of early versus conventional cessation of hydrocortisone in patients experiencing septic shock. It aims to assess the incidence of adverse events associated with corticosteroid use, such as hyperglycemia and hypernatremia, during the recovery phase of septic shock. Patients will receive either hydrocortisone or a normal saline solution, and their outcomes will be monitored to determine the optimal approach for tapering off hydrocortisone. The study is conducted in an intensive care setting at Siriraj Hospital, focusing on patients who have been stabilized on vasopressors.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with septic shock who are currently receiving hydrocortisone and catecholamines.
Not a fit: Patients who are terminally ill, pregnant, or require long-term steroid use for other medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with septic shock, potentially reducing adverse effects associated with corticosteroid treatment.
How similar studies have performed: Previous studies have explored corticosteroid use in septic shock, but this specific comparison of early versus conventional cessation is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient \>= 18 years old * Diagnosis Septic shock from the definition of SEPSIS III criteria in intensive care unit or medicine ward or surgical ward at Siriraj hospital * Received at least 1 catecholamines and hydrocortisone at least 200 mg/d * Maintain mean arterial pressure \>= 65 mmHg even if titrate down catecholamines until low dose (\<=0.1 mcg/kg/min) Exclusion Criteria: * Patient sign Do not resuscitation and terminally ill * Pregnancy * Need long term steroid use due to other medical condition
Where this trial is running
Bangkok
- Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Surat Tongyoo, Doctor — Mahidol University
- Study coordinator: Surat Tongyoo, Doctor
- Email: surat.ton@mahidol.ac.th
- Phone: +24197764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.