NCT05818826

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Septic Shock
• Adverse Event
• Hydrocortisone
• Hyperglycemia
• Hypernatremia
• Muscle Weakness
• Superimposed Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-07-05
• Primary completion: 2025-04-01
• Completion: 2025-05-01
• First posted: 2023-04-19
• Last updated: 2024-04-05

Locations

1 site across 1 country: Thailand