Early Versus Conventional Cessation of Hydrocortisone in Septic Shock (CESSHYDRO)

Mahidol University

Status and phase: Enrolling; Phase 2

Conditions: Hydrocortisone; Adverse Event; Hypernatremia; Hyperglycemia; Muscle Weakness; Septic Shock; Superimposed Infection

Treatments: Drug: Hydrocortisone and normal saline solution; Drug: normal saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05818826

SI 012/2023

Details and patient eligibility

About

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.

Full description

According to secondary outcomes of several studies analyzed in systemic review was shown adverse events from corticosteroid uses including hyperglycemia, hypernatremia, muscle weakness, and superimposed infection. This trials will compare composite adverse events in early versus conventional cessation of hydrocortisone in septic shock.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

160 participants in 2 patient groups, including a placebo group

early cessation group

Experimental group

Description:

The pharmacist uses 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. The experimental starts after required dose of vasopressor less than 0.1 mcg/kg/min. The nurse serially records capillary blood glucose and serum sodium following the doctor's order.

Treatment:

Drug: normal saline solution

conventional cessation group

Placebo Comparator group

Description:

The pharmacist prepared hydrocortisone and 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. The nurse serially records capillary blood glucose and serum sodium following the doctor's order.

Treatment:

Drug: Hydrocortisone and normal saline solution