A Phase 2 interventional study of normal saline solution and Hydrocortisone and normal saline solution in Septic Shock, Adverse Event and Hydrocortisone, sponsored by Mahidol University. Recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by Mahidol University · Phase 2, Interventional, and Treatment
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 160 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: normal saline solution
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.
Drug: Hydrocortisone and 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.
Also known as: early cessation group
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.
Also known as: conventional cessation group
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
Time frame: within 14 days after randomization or until discharge from hospital, whichever came first
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
Time frame: 28-day mortality from any cause start until 28 day after randomization or until discharge from hospital, whichever came first
Concentration of insulin needed due to hyperglycemia
Total insulin used to lower capillary blood sugar if level of glucose more than 180 mg/dL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 28 days
Duration of ICU length of stay
Duration measured as days from randomization until discharge from ICU
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 28 days after randomization or until discharge from hospital, whichever came first
Plan to share: Yes — Anonymous identification data will be prepared per request, after study publication 6 months
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: 6 months post study publication
Access criteria: Request to principal investigation, after protocol approval from ethical committee
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Apr 2025, 21 months after the start.
Of 36 non-industry phase 2 interventional studies under Shock, Septic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's planned 21 months is below that.
Counting every sponsor, half of 41 studies reached it within 29 months; a quarter within 15 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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