Sepsis septic shock
Conditions
Interventions
Intervention is defined in each domain, which is descrived in each domain protocol.
Hemodynamic management domain:
Patient recieves either intervention or control treatmet as folows for 48 hours or
Sponsors
Yamamoto Ryo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged 18 years or older Diagnosed as sepsis (based on Sepsis-3 criteria) Requiring intensive care Written consent has been obtained from the subject or proxy Hemodynamic management domain: Mild tachycardia (HR 95-129bpm) within 72 hours after the initiation of intensive care (The start of intensive care is defined as the time of admission to the intensive care unit (ICU) or when the attending physician begins frequent monitoring of consciousness, respiration, and heart rate if the patient is not admitted to the ICU.) Infection control domain with antibiotic-containing dressing: Central venous line (including hemodialysis catheter, peripherally inserted central venous catheter) is newly inserted Short-term hydrocortisone therapy for septic shock: A patient who, within 72 hours after initiation of intensive care, had a serum lactate level >2.0 mmol/L and required norepinephrine for hypotension despite receiving more than 1,000 mL of fluids. Hydrocortisone was administered at 200 mg per day by continuous or intermittent intravenous infusion.
Exclusion criteria
Exclusion criteria: Participation in another clinical trial requiring a treatment intervention that is considered to have an interaction with any of intervention of this trial(Thoroughly assess the potential for interaction scientifically and statistically.) At the time of diagnosis as sepsis, withhold/withdrwal is determined Detainees in correctional facilities and immigration detention centers Ineligible for, or not participating in, any domain studies Physician in charge considers the particitation is inappropriate Hemodynamic management domain: Ventricular tachycardia or ventricular fibrillation Antiarrhythmic medication is being administered intravenously Landiolol is contraindicated Highly anticipated to die within 24 h 72 hours past after the initiation of intensive care for sepsis Previously participated in this particular domain Infection control domain with antibiotic-containing dressing: Allergy to chlorhexidine Having skin disease in the whole body Having skin lesion at the site of catheter insertion Catheter is inserted as the exchange over the guidewire Antibiotics impregnated catheter is used 72 hours past after the initiation of intensive care for sepsis Previously participated in this particular domain Short-term hydrocortisone therapy for septic shock: More than 12 hours after the initiation of norepinephrine. More than 72 hours after the start of intensive care. Previously enrolled in this domain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day survival from the initiation of intensive care for sepsis Hemodynamic management domain: Composite outcome of mortality and/or ischemic/thrombotic major vascular event at 30 days from the initiation of intensive care for sepsis Infection control domain with antibiotic-containing dressing: Catheter colonization Short-term hydrocortisone therapy for septic shock: Vasopressor-free days within 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospital-/ICU-/Ventilator-/RRT-free days up to 90 days from the initiation of intensive care for sepsis 30-day mortality Hemodynamic management domain: In-hospital mortality 30-day survival to discharge to home Newly developed arrhythmia up to 30 days from the initiation of intensive care for sepsis and its duration Ischemic/thrombotic major vascular event at 30 days from the initiation of intensive care for sepsis Vasopressor-free days up to 30 days 90-day mortality Hospital/ICU/Ventilator/RRT-free days within 90 days Infection control domain with antibiotic-containing dressing: Incidence rate of major catheter-related infections Clinical information at 30 days/90 days after the start of intensive care Length of antibiotic use Hospitalization medical expenses Adverse events related to chlorhexidine and/or catheter Short-term hydrocortisone therapy for septic shock: In-hospital mortality 90-day mortality Hospital-free, ICU-free, ventilator-free, and RRT-free days up to day 90. Actual duration of hydrocortisone administration (total days) | — |
Contacts
Public ContactRyo Yamamoto
Keio University Hospital, Department of Emergency and Critical Care Medicine
Outcome results
None listed