Adverse Event, Hydrocortisone, Hyperglycemia, Hypernatremia, Muscle Weakness, Septic Shock, Superimposed Infection
Conditions
Keywords
septic shock, composite adverse events, hydrocortisone, hyperglycemia, hypernatremia, muscle weakness, superimposed infection
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.
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.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of insulin needed due to hyperglycemia | within 14 days after randomization or until discharge from hospital, whichever came first | Total insulin used to lower capillary blood sugar if level of glucose more than 180 mg/dL |
| Number of participants with hypoglycemia | within 14 days after randomization or until discharge from hospital, whichever came first | Number of participants with capillary blood glucose \< 80 mg/dL |
| Number of participants with capillary blood glucose ≥ 150 mg/dL | within 14 days after randomization or until discharge from hospital, whichever came first | Number of participants with capillary blood glucose ≥ 150 mg/dL |
| Time of vasopressor reinitiation until 14 day after randomization or until hospital discharge | within 14 days after randomization or until discharge from hospital, whichever came first | Duration measured as hours from off vasopressor until re-initiation at least 0.05 mcg/kg/min until 14 day after randomization or until hospital discharge |
| Time to need of fluid bolus | within 14 days after randomization or until discharge from hospital, whichever came first | Duration measured as hours from randomization until fluid bolus at least 250 ml in 10-15 minutes until 14 day after randomization or until hospital discharge |
| Time to reversal of shock | within 14 days after first dose of hydrocortisone or until discharge from hospital, whichever came first | Duration measured as hours from randomization until off vasopressor |
| Number of participants with New onset of infection within 28 days | 28 days | Number of participants with New onset of infection within 28 days |
| Number of participants with 28-day mortality from any cause or until discharge from hospital | 28-day mortality from any cause start until 28 day after randomization or until discharge from hospital, whichever came first | death from any cause until 28-day after randomization or until discharge from hospital |
| Duration of Ventilator free day | 14 days after first dose hydrocortisone or until discharge from hospital, whichever came first | Duration measured as hours from off ventilator until on ventilator or reintubation |
| Number of participants with Lung injury score at day 1, day 3, day 7 after first dose hydrocortisone | 7 days after randomization or until discharge from hospital, whichever came first | Number of participants with Lung injury score at day1, day3, day7 after first dose hydrocortisone |
| Level of minimum and maximum mean arterial pressure | within 14 days after randomization or until discharge from hospital, whichever came first | Level of minimum and maximum mean arterial pressure until 14 days after randomization or until hospital discharge |
| Number of participants with Alive days in 28 days with free mechanical ventilator | 28 days after randomization or until discharge from hospital, whichever came first | Number of participants who survive in 28 days with free mechanical ventilator |
| Number of participants with Alive days in 28 days with free renal replacement therapy | 28 days after randomization or until discharge from hospital, whichever came first | Number of participants who survive in 28 days with free mechanical ventilator |
| Number of participants with Alive days in 28 days with free organ supports | 28 days after randomization or until discharge from hospital, whichever came first | Number of participants who survive in 28 days with free mechanical ventilator |
| Duration of ICU length of stay | 14 days after first dose hydrocortisone or until discharge from hospital, whichever came first | Duration measured as days from randomization until discharge from ICU |
Countries
Thailand
Contacts
Primary ContactSurat Tongyoo, Doctor
Backup ContactKolanya Kangwanyotsak, Doctor
Outcome results
None listed