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

NCT05818826 Phase 2 UNKNOWN

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.

Details

Lead sponsor	Mahidol University
Phase	Phase 2
Status	UNKNOWN
Enrolment	160
Start date	2023-07-05
Completion	2025-05

Conditions

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

Interventions

• normal saline solution
• Hydrocortisone and normal saline solution

Primary outcomes

• Composite adverse events of early versus conventional cessation of hydrocortisone — within 14 days after randomization or until discharge from hospital, whichever came first
  including level of capillary blood glucose \>= 180mg/dL(Hyperglycemia) , Plasma level of sodium\>= 150mmol/L(Hypernatremia), new onset of infection , and neuromuscular weakness(muscular impairment rating scale\>1

Countries

Thailand