Septic Shock Clinical Trial
— CESSHYDROOfficial title:
Composite Adverse Events Compared Early Versus Conventional Cessation of Hydrocortisone in Patients With Septic Shock: Randomized-controlled Trial
NCT number | NCT05818826 |
Other study ID # | SI 012/2023 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 5, 2023 |
Est. completion date | May 2025 |
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.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | May 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Number of participants with New onset of infection within 28 days | Number of participants with New onset of infection within 28 days | 28 days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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