Early Versus Conventional Cessation of Hydrocortisone in Septic Shock (NCT05818826) | Clinical Trial Compass
UnknownPhase 2
Early Versus Conventional Cessation of Hydrocortisone in Septic Shock
Thailand160 participantsStarted 2023-07-05
Plain-language summary
Septic shock is one of the causes of death in ICU and hospital. Refractory shock is the problem which healthcare providers should recognize though it is difficult to handle with. The corticosteroid called hydrocortisone is one of the treatment in refractory septic shock which requires vasopressor to maintain blood pressure. In recovery phase of septic shock and weaning off vasopressor, there is no definite way to taper off hydrocortisone.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 2 and compares stopping hydrocortisone early versus the conventional timing in septic shock — what does that early stage mean for how much is already known about whether one approach is safer than the other?
2The trial is specifically tracking side effects like high blood sugar, high sodium levels, muscle weakness, and new infections as its main outcomes — given my current health situation, am I at particular risk for any of those complications regardless of which timing approach is used?
3The recruitment status for this trial is listed as 'unknown' — does that mean it may not be actively enrolling patients right now, and would it even be a realistic option for me to pursue?
4Since this study is looking at when to stop hydrocortisone rather than whether to use it, how does the timing of stopping this medication compare to what you would do as my doctor in standard care for septic shock?
5Are there standard treatment protocols for tapering or stopping hydrocortisone in septic shock that already have stronger evidence behind them, and would those be a better path for me before considering participation in a Phase 2 trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite adverse events of early versus conventional cessation of hydrocortisone
Timeframe: within 14 days after randomization or until discharge from hospital, whichever came first