Septic shock
Conditions
Interventions
[CRT-guided permissive hypotension with conventional-timing vasopressin initiation group] After achieving an initial MAP of 65 mmHg during early resuscitation, the target MAP will be gradually reduce
3 seconds is maintained. To minimize the risk of potential organ hypoperfusion, the lower limit of the target MAP will be set at >
=50 mmHg. Vasopressin will be initiated in combination when a norepinephrine dose of >
=0.1 ug/kg/min is required.
[Usual blood pressure management with standard-timing vasopressin initiation group] MAP will be maintained at 65 mmHg in accordance with the 2021 Surviving Sepsis Campai
=0.1 ug/kg/min is required.
[CRT-guided permissive hypotension with early vasopressin initiation group] After achieving an initial MAP of 65 mmHg during early resuscitation, the target MAP will be gr
=0.3 ug/kg/min is required.
[Usual blood pressure management with early vasopressin initiation group] MAP will be maintained at 65 mmHg in accordance with the 2021 Surviving Sepsis Campaign Guideli
=0.3 ug/kg/min is required.
Sponsors
Akira Endo, Department of Acute Critical Care and Disaster Medicine, Institute of Science Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals who meet all the following criteria: 1. Patients who are aged 18 years or older 2. Patients who are diagnosed with septic shock clinically (irrespective of out-of-hospital or in-hospital onset) 3. Patients who admitted to intensive care unit.
Exclusion criteria
Exclusion criteria: Individuals who met either of the following criteria: 1. Patients who have been on vasopressors for 3 or more hours 2. Patients who have the advanced directives restricting implementation of the standard critical care (e.g., catecholamine use, mechanical ventilation, and renal replacement therapy) 3. Patients experiencing cardiac arrest before randomization 4. Patients with other diseases that require stricter blood pressure control than for maintaining hemodynamics in septic shock 5. Patients who need to be arrested, detained, or put in custody by law enforcement or legal agencies 6. Patients who refuse to participate in the trial 7. Patient who is ultimately unable to provide consent, either by themselves or through a legally authorized representative 8. Patients deemed ineligible to participate by a clinical physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vasopressor-free days at 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ischemia-related adverse events within 72 hours after randomization (myocardial infarction, ischemic stroke, intestinal necrosis, or irreversible peripheral limb ischemia). 2. Arrhythmias within 72 hours after randomization (ventricular tachycardia or supraventricular arrhythmias with hemodynamic compromise). 3. Hemorrhagic events within 72 hours after randomization. 4. All-cause mortality at 28 and 90 days after randomization. 5. Lactate clearance at 24 hours after randomization. 6. SOFA score at 72 hours after randomization. 7. Ventilator-free days at 28 days. 8. Renal replacement therapy-free days at 28 days. 9. KDIGO criteria at 28 days or at hospital discharge 10. Win ratio, defined in the following hierarchical order: (i)90-day mortality, (ii) ventilator days, (iii) renal replacement therapy days, and (iv) vasopressor days. | — |
Countries
Japan
Contacts
Public ContactAkira Endo
Institute of Science Tokyo Department of Acute Critical Care and Disaster Medicine
Outcome results
None listed