Septic shock
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with septic shock who are aged 65 years or older and requires management in an intensive care unit
Exclusion criteria
Exclusion criteria: 1. Patients who are highly likely to be transferred to another hospital within 72 h of randomisation 2. Patients who have been on vasopressors for 3 or more hours 3. Patients experiencing cardiac arrest before randomisation 4. Patients who are diagnosed with coronavirus disease 2019 5. Patients who have the advanced directives restricting implementation of the standard critical care (e.g., catecholamine use, mechanical ventilation, and renal replacement therapy) 6. Patients with other diseases that require stricter blood pressure control than for maintaining haemodynamics in septic shock (uncontrollable active bleeding, aneurysms, arterial dissection, etc.) 7. Patients participating in other clinical trials that involve interventions 8. Patients who need to be arrested, detained, or put in custody by law enforcement or legal agencies 9. Patients who refuse to participate in the trial 10. Patients deemed ineligible to participate by a clinical physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 90 days after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lactate clearance at 24 hours after randomization 2. Incidence rates of adverse events (arrhythmia, thrombosis, ischemia, or hemorrhage) during the 72 hours after randomization 3. All-cause mortality rate at 28 days 4. Sepsis-related mortality at 28 days after randomization 5. Ventilator-free days at 28 days after randomization 6. Renal replacement therapy-free days at 28 days after randomization 7. Catecholamine-free days at 28 days after randomization 8. Sepsis-related mortality at 90 days after randomization | — |
Countries
Japan
Contacts
Tokyo Medical and Dental University Trauma and Acute Critical Care Center