Septic shock
Conditions
Interventions
control group:a. Dosage regimen: Hydrocortisone 200mg/day, continuous intravenous infusion, fixed treatment for 7 days.
b. Intervention time: After completing 7 days of treatment, regardless of the us
Or if the patient reaches the shock relief criteria in advance (stopping vasoactive drugs and MAP >= 65mmHg for more than 24 hours), the medication can be stopped after judgment by clinical physicians
experimental group:a. Dosage regimen: Hydrocortisone 200mg/day, continuous intravenous infusion.
b. Intervention time: The patient can stop taking the medication once they meet the stopping criteria.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Be at least 18 years old and have signed a written informed consent form. If the patient is unable to sign, it must be signed by their legally authorized representative (LAR); In case of emergency, if the representative's consent cannot be obtained immediately, the study can be included in accordance with relevant regulatory provisions and deferred consent from the patient or representative can be obtained as soon as possible. (2) There are clinically or microbiologically confirmed infection foci, or clear suspected evidence of infection. (3) Septic shock: a. After sufficient fluid resuscitation, vasopressors are still needed to maintain a mean arterial pressure of >= 65 mmHg; and b. Serum lactate level>2 mmol/L. (4) Demand for vasoactive drugs: a. I am currently receiving continuous treatment with vasoactive drugs to maintain systolic blood pressure>90 mmHg or mean arterial pressure (MAP) >= 65 mmHg (or perfusion pressure target set by the attending physician), and have been using it continuously for at least 6 hours but not more than 24 hours. b. The drug dosage must meet any of the following conditions: dopamine >= 15 µ g/kg/min; Or adrenaline/norepinephrine dose >= 0.25 µ g/kg/min (or at least >= 1 mg/h); Or use other vasoconstrictors to achieve the same blood pressure support target (in the absence of low blood volume). (5) The time interval between self admission to the ICU and planned randomization is less than 7 days. (6) At the time of randomization, mechanical ventilation support (including invasive ventilation, non-invasive ventilation, or BiPAP/CPAP) was being received.
Exclusion criteria
Exclusion criteria: (1) The time to diagnose all inclusion criteria has exceeded 24 hours. (2) Clinicians expect to prescribe systemic corticosteroids (excluding nebulized or inhaled corticosteroids) for indications other than septic shock, such as autoimmune diseases, acute exacerbation of chronic obstructive pulmonary disease, etc. (3) The risk of death during this hospitalization is extremely high, and the attending physician, patient, or alternative decision maker does not promise to take active treatment. (4) Due to underlying diseases, life expectancy is extremely short (possibly less than 1 month or death within 90 days) (5) A decision has been made to restrict or revoke active treatment. (6) Known to be pregnant or breastfeeding. (7) There has been gastrointestinal bleeding in the past 6 weeks, and any conditions that may pose a risk of bleeding have been assessed by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the number of days without vasoactive drugs between two groups of patients within 28 days after randomization.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 90 day all-cause mortality rate;ICU mortality rate and in-hospital mortality rate;Incidence of chronic critical illness (CCI);Shock reversal time;Number of days without organ support within 28 days;ICU length of stay and total length of stay; | — |
Countries
China
Contacts
Public ContactQin Wu
West China Hospital of Sichuan University
Outcome results
None listed