Clinical trial
Composite Adverse Events Compared Early Versus Conventional Cessation of Hydrocortisone in Patients With Septic Shock: Randomized-controlled Trial
Name
SI 012/2023
Description
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.
Trial arms
Trial start
2023-07-05
Estimated PCD
2025-04-01
Trial end
2025-05-01
Status
Recruiting
Phase
Early phase I
Treatment
normal saline solution
Prepare 100 ml of normal saline solution, packed out in the same format, dose, and administration of the drug were exactly the same as in the conventional cessation group.
Arms:
early cessation group
Other names:
early cessation group
Hydrocortisone and normal saline solution
Prepare hydrocortisone with normal saline solution 100 ml starts dose at least 200 mg/day according to doctor's order after patient meets the criteria of refractory septic shock then continues conventional cessation of hydrocortisone according to doctor's order after required dose of vasopressor less than 0.1 mcg/kg/min.
Arms:
conventional cessation group
Other names:
conventional cessation group
Size
160
Primary endpoint
Composite adverse events of early versus conventional cessation of hydrocortisone
within 14 days after randomization or until discharge from hospital, whichever came first
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pharmacist who does not involve in patient enrollment nor treatment will prepared hydrocortisone or placebo in the identical container, before the study drug will be discontinued from patients , according to their treatment arm.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}
Updated at
2024-04-05
1 organization
Organization
Mahidol University