None listed
Conditions
Interventions
Medical Device : All participants are randomly assigned to treatment groups and controls by random assignments. The control group receives normal sepsis shock treatment, and the treatment group begins
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study includes septic shock patients aged 19 or older who meet all of the following conditions: (1) Adults 19 years of age or older (2) Community aquired infection: Infection occurring within 48 hours of hospitalization (3) Sepsis (Definition of SEPSIS-3): Infection + 2 or more points of SOFA compared to base (4) Septic shock (Definition of SEPSIS-3): use of vasopressor + Lactic acid > 2 mmol/L (5) Use of vasopressor: 0.2 mcg/kg/min of norepinephrine for more than one hour.
Exclusion criteria
Exclusion criteria: It is excluded from the study if one or more of the following conditions apply: (1) Under 19 years of age or over 80 years of age; (2) Patients who have elapsed more than 24 hours after septic shock occurs (3) Severe neutrophil count reduction: ANC < 500/microL (4) Patients who have received organ transplants within 12 months (5) Blood cancer patients (6) Solid cancer patients who have undergone chemotherapy within three months (7) Patients under dialysis treatment for chronic renal failure (8) Patients with a screening SOFA score of 12 or higher (9) Patients with adverse reactions to heparin (e.g. HIT) (10) Patients who have applied in ECMO(Extracorporeal Membrane Oxygenation) treatment (11) Pregnant women and lactating women (12) Patients participating in other clinical trials (However, not excluded from studies without arbitration, e.g. cohort observation studies) (13) Patients with ECOG of 3 or more points (14) Patients who are expected to die within six months due to a companion disease (15) Patients who have performed CPR with Cardiac arrest (16) Do-not-resuscitation (DNR) status patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the use of vasopressor(cumulative vasopressor index, CVI) after random assignments | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Sequential Organ Failure Assessment (SOFA) scores after random assignments;Changes in Disseminated Intravascular Coagulation (DIC) scores after random assignments;Changes in IL-1ß, IL-6, IL-8, IL-10, TNF-a after random assignments;Mortality;Hospital mortality rates;Hospital days;ICU days and ICU-free day;Ventilator-free days and vasopressor-free days | — |
Countries
Korea, Republic of
Contacts
Public Contacteunmi cho
Asan Medical Center
Outcome results
None listed