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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early cessation group | Experimental | 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. |
|
| conventional cessation group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| normal saline solution | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite adverse events of early versus conventional cessation of hydrocortisone | 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 | within 14 days after randomization or until discharge from hospital, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with 28-day mortality from any cause or until discharge from hospital | death from any cause until 28-day after randomization 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Surat Tongyoo, Doctor | Contact | +24197764 | surat.ton@mahidol.ac.th | |
| Kolanya Kangwanyotsak, Doctor | Contact | +24197764 | tkolanya@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Surat Tongyoo, Doctor | Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University | Recruiting | Bangkok | 10700 | Thailand |
Anonymous identification data will be prepared per request, after study publication 6 months
6 months post study publication
Request to principal investigation, after protocol approval from ethical committee
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D006943 | Hyperglycemia |
| D006955 | Hypernatremia |
| D018908 | Muscle Weakness |
| D015163 | Superinfection |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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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.
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|
| Hydrocortisone and normal saline solution | Drug | 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. |
|
|
| Concentration of insulin needed due to hyperglycemia |
Total insulin used to lower capillary blood sugar if level of glucose more than 180 mg/dL |
| within 14 days after randomization or until discharge from hospital, whichever came first |
| Number of participants with hypoglycemia | Number of participants with capillary blood glucose < 80 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 | Number of participants with capillary blood glucose ≥ 150 mg/dL | within 14 days after randomization or until discharge from hospital, whichever came first |
| Time of vasopressor reinitiation until 14 day after randomization or until hospital discharge | 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 | within 14 days after randomization or until discharge from hospital, whichever came first |
| Time to need of fluid bolus | 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 | within 14 days after randomization or until discharge from hospital, whichever came first |
| Time to reversal of shock | Duration measured as hours from randomization until off vasopressor | within 14 days after first dose of hydrocortisone or until discharge from hospital, whichever came first |
| Number of participants with New onset of infection within 28 days | Number of participants with New onset of infection within 28 days | 28 days |
| Duration of ICU length of stay | Duration measured as days from randomization until discharge from ICU | 14 days after first dose hydrocortisone or until discharge from hospital, whichever came first |
| Duration of Ventilator free day | Duration measured as hours from off ventilator until on ventilator or reintubation | 14 days after first dose hydrocortisone or until discharge from hospital, whichever came first |
| Number of participants with Lung injury score at day 1, day 3, day 7 after first dose hydrocortisone | Number of participants with Lung injury score at day1, day3, day7 after first dose hydrocortisone | 7 days after randomization or until discharge from hospital, whichever came first |
| Level of minimum and maximum mean arterial pressure | Level of minimum and maximum mean arterial pressure until 14 days after randomization or until hospital discharge | within 14 days after randomization or until discharge from hospital, whichever came first |
| Number of participants with Alive days in 28 days with free mechanical ventilator | Number of participants who survive in 28 days with free mechanical ventilator | 28 days after randomization or until discharge from hospital, whichever came first |
| Number of participants with Alive days in 28 days with free renal replacement therapy | Number of participants who survive in 28 days with free mechanical ventilator | 28 days after randomization or until discharge from hospital, whichever came first |
| Number of participants with Alive days in 28 days with free organ supports | Number of participants who survive in 28 days with free mechanical ventilator | 28 days after randomization or until discharge from hospital, whichever came first |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D009894 | Opportunistic Infections |
| D011282 |
| Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |