Hemodynamic Phenotype and Capillary Refill Time-targeted Resuscitation Strategy (A2)
Septic Shock
About this trial
This is an interventional treatment trial for Septic Shock
Eligibility Criteria
Inclusion Criteria:
- Consecutive adult patients (≥ 18 years) with septic shock according to Sepsis-3 consensus conference (septic shock defined as suspected or confirmed infection, plus hyperlactatemia and NE requirements due to persistent hypotension, after a fluid load of at least 1000 mL in one hour)
Exclusion Criteria:
- More than 4 hours since septic shock diagnosis,
- Anticipated surgery or acute hemodialysis procedure to start during the 6h intervention period
- Active bleeding,
- Do not resuscitate status,
- Child B-C Cirrhosis
- Underlying disease process with a life expectancy < 90 days and/or the attending clinician deems aggressive resuscitation unsuitable
- Refractory shock (high risk of death within 24h)
- Pregnancy
- Concomitant severe acute respiratory distress syndrome.
- Patients in whom CRT cannot be accurately assessed.
Sites / Locations
- Pontificia Universidad Católica de ChileRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Usual Care Group (UC)
Capillary-refill time and phenotyping group
- Patients allocated to the usual care group will be managed by the clinical staff according to usual practice at their sites including decisions about hemodynamic and perfusion monitoring, and all treatments, but should follow general recommendations of the Surviving Sepsis Campaign to avoid extremes of clinical practice. This includes basic hemodynamic targets such as a MAP >65 mmHg, HR (heart rate) <120 beats per minute (BPM), arterial oxygen saturation (SaO2) >94%, Hb > 7 gr/dl, and the use of NE as the first vasopressor and crystalloids as the fluid of choice.
Patients w/normal baseline CRT will be periodically monitored. Patients with abnormal CRT and septic shock will be categorized according to pulse pressure (PP). If <40 mmHg, will go to fluid responsiveness (FR) assessment. FR (-) patients will undergo cardiac echo to rule out significant dysfunction. Fluid boluses will be administered in 30 min intervals and repeated as needed if CRT is still abnormal. Patients with PP ≥40 mmHg will proceed according to diastolic pressure (DAP). If ≥50 mmHg will move to FR assessment. If <50 mmHg NE will be increased for MAP >65 mmHg and DAP ≥50 mmHg w/CRT assessed 1 h after. NE will be increased in 0.1 mcg/k/m increments up to 0.5 mcg/k/m. If CRT is normal, patients will proceed to periodic monitoring. Patients with persistent abnormal CRT or that reached NE safety limit will proceed directly to echo. Patients that correct CRT with first tier interventions will not be subjected to obligatory echo but will just proceed to periodic monitoring.