Septic shock
Conditions
Interventions
This is a randomized, controlled clinical trial with two parallel arms, open label, conducted in an intensive care unit. A total of 64 adult participants with septic shock will be randomly allocated i
Sponsors
Fundação Universidade Caxias do Sul Hospital Geral
Hospital Geral de Caxias do Sul
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults aged 18 years or older; suspected or confirmed septic shock according to the Third International Consensus Definitions for Sepsis and Septic Shock; requirement for vasopressor therapy to maintain a mean arterial pressure of 65 millimeters of mercury or higher after adequate fluid resuscitation; serum lactate level of 2 millimoles per liter or higher; initiation of norepinephrine within the previous 12 hours; admission to the intensive care unit of Hospital Geral de Caxias do Sul; written informed consent provided by the participant or legal representative
Exclusion criteria
Exclusion criteria: Limitation of life sustaining treatment or do not resuscitate order; chronic dialysis or indication for renal replacement therapy within the next 8 hours; age younger than 18 years; hypotension not related to sepsis; traumatic brain injury; recent stroke; scleroderma; sickle cell disease; significant arrhythmias; pregnancy; refusal to participate in the study; severe peripheral vascular disease; hemorrhagic shock; cardiogenic shock; obstructive shock
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to demonstrate that the perfusion-guided permissive hypotension strategy (mean arterial pressure target of 50–55 mmHg associated with a capillary refill time = 3 seconds) is non-inferior to the conventional strategy (mean arterial pressure target of 65–75 mmHg) with respect to the change in the renal component of the Sequential Organ Failure Assessment (renal SOFA) score between randomization and 72 hours, considering as the non-inferiority criterion an upper limit of the 95% confidence interval of the between-group difference of less than 1 point in the renal SOFA score | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to demonstrate that the perfusion-guided permissive hypotension strategy is non-inferior to the conventional strategy with respect to all-cause mortality up to 28 days after randomization;It is expected to observe lower cumulative exposure to norepinephrine and other vasopressors within the first 48 hours after randomization in the perfusion-guided (capillary refill time–guided) strategy;It is expected to observe a shorter time to complete vasopressor discontinuation after randomization in the perfusion-guided (capillary refill time–guided) group;It is expected that no difference will be observed in the evolution of serum lactate levels measured at 6, 12, 24, and 72 hours after randomization between the studied strategies;It is expected that no difference will be observed in intensive care unit and hospital length of stay between the studied strategies ;It is expected that no difference will be observed in the incidence of acute kidney injury between the studied strategies, as defined by the Kidney Disease Improving Global Outcomes criteria;It is expected that no difference will be observed in the need for renal replacement therapy during hospitalization between the studied strategies;It is expected that no difference will be observed in the number of ventilator-free days up to 28 days after randomization between the studied strategies;It is expected that no difference will be observed in global organ dysfunction, assessed by the Sequential Organ Failure Assessment score, at 72 hours after randomization between the studied strategies ;It is expected to observe a higher incidence of vasopressor-related adverse events, including arrhythmias and peripheral ischemia, in the conventional mean arterial pressure–guided strategy compared with the perfusion-guided strategy;It is expected to observe a shorter time to capillary refill time normalization after randomization in the perfusion-guided strategy | — |
Countries
Brazil
Contacts
Public ContactEmerson da Silva
Hospital Geral de Caxias do Sul
Outcome results
None listed