RECRUITINGPhase 2INTERVENTIONAL

Early Versus Conventional Cessation of Hydrocortisone in Septic Shock

Composite Adverse Events Compared Early Versus Conventional Cessation of Hydrocortisone in Patients With Septic Shock: Randomized-controlled Trial

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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) Who Should NOT Join This Trial: - Patient sign Do not resuscitation and terminally ill - Pregnancy - Need long term steroid use due to other medical condition Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

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.

DRUG

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.

Locations (1)

Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Thailand