RecruitingPhase 2NCT05818826

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

Sponsor

Mahidol University

Enrollment

160 participants

Start Date

Jul 5, 2023

Study Type

INTERVENTIONAL

Conditions

Muscle Weakness Septic Shock Hyperglycemia Adverse Event Hydrocortisone Hypernatremia Superimposed Infection

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria3

Patient sign Do not resuscitation and terminally ill
Pregnancy
Need long term steroid use due to other medical condition

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Interventions

DRUGnormal 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.

DRUGHydrocortisone 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.