Clinical trial NCT05818826: Early Versus Conventional Cessation of Hydrocortisone in Septic Shock
Official title: Composite Adverse Events Compared Early Versus Conventional Cessation of Hydrocortisone in Patients With Septic Shock: Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Septic Shock
Adverse Event
Hydrocortisone
Hyperglycemia
Hypernatremia
Muscle Weakness
Superimposed Infection
Keywords: septic shock
composite adverse events
hydrocortisone
hyperglycemia
hypernatremia
muscle weakness
superimposed infection
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pharmacist who does not involve in patient enrollment nor treatment will prepared hydrocortisone or placebo in the identical container, before the study drug will be discontinued from patients , according to their treatment arm.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite adverse events of early versus conventional cessation of hydrocortisone
timeFrame: within 14 days after randomization or until discharge from hospital, whichever came first
Secondary outcomes:
measure: Number of participants with 28-day mortality from any cause or until discharge from hospital
timeFrame: 28-day mortality from any cause start until 28 day after randomization or until discharge from hospital, whichever came first
measure: Concentration of insulin needed due to hyperglycemia
timeFrame: within 14 days after randomization or until discharge from hospital, whichever came first
measure: Number of participants with hypoglycemia
timeFrame: within 14 days after randomization or until discharge from hospital, whichever came first
measure: Number of participants with capillary blood glucose ≥ 150 mg/dL
timeFrame: within 14 days after randomization or until discharge from hospital, whichever came first
measure: Time of vasopressor reinitiation until 14 day after randomization or until hospital discharge
timeFrame: within 14 days after randomization or until discharge from hospital, whichever came first
measure: Time to need of fluid bolus
timeFrame: within 14 days after randomization or until discharge from hospital, whichever came first
measure: Time to reversal of shock
timeFrame: within 14 days after first dose of hydrocortisone or until discharge from hospital, whichever came first
measure: Number of participants with New onset of infection within 28 days
timeFrame: 28 days
measure: Duration of ICU length of stay
timeFrame: 14 days after first dose hydrocortisone or until discharge from hospital, whichever came first
measure: Duration of Ventilator free day
timeFrame: 14 days after first dose hydrocortisone or until discharge from hospital, whichever came first
measure: Number of participants with Lung injury score at day 1, day 3, day 7 after first dose hydrocortisone
timeFrame: 7 days after randomization or until discharge from hospital, whichever came first
measure: Level of minimum and maximum mean arterial pressure
timeFrame: within 14 days after randomization or until discharge from hospital, whichever came first
measure: Number of participants with Alive days in 28 days with free mechanical ventilator
timeFrame: 28 days after randomization or until discharge from hospital, whichever came first
measure: Number of participants with Alive days in 28 days with free renal replacement therapy
timeFrame: 28 days after randomization or until discharge from hospital, whichever came first
measure: Number of participants with Alive days in 28 days with free organ supports
timeFrame: 28 days after randomization or until discharge from hospital, whichever came first
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Surat Tongyoo, Doctor
role: PRINCIPAL_INVESTIGATOR
References: