circulatory shock Circulatory failure in sepsis
Conditions
Interventions
Recruited patients will be randomized to intervention arm (CRT-P) or usual care
(UC).
Usual Care (UC) group:
Patients allocated to the UC group will be managed by the clinical staff
according to us
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult patients (>= 18 years) with septic shock according to Sepsis-3 consensus conference. Septic shock is defined as suspected or confirmed infection, the presence of increased lactate levels and the requirements for the administration of a vasopressor to maintain blood pressure following a fluid load of at least 1000mL in 1h.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The hierarchical composite of all-cause mortality within 28 days, time to cessation of vital support (truncated at 28 days) and length of hospital stay (truncated at 28 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality by all causes at 28 days following randomization Vital support free days within 28 days following randomization The number of calendar days between randomization and 28 days later that the patient is alive and with no requirement of cardiovascular, respiratory and renal support. Patients who die within 28 days will have zero days counted for this variable, irrespective of vital support status. Resolution of cardiovascular failure implies complete stopping of vasopressor support for at least 24 consecutive hours. Resolution of respiratory failure implies extubation/liberation from mechanical ventilation for at least 48 hours. Resolution of renal failure implies liberation of renal replacement therapy for at least 72 hours in those receiving continuous replacement modalities and at least 5 days for those receiving intermittent ones. Length of hospital stay at 28 days following randomization. Number of days remaining hospitalized (from randomization up to hospital discharge), truncated at day 28. | — |
Countries
Netherlands
Outcome results
None listed