Septic Shock
Conditions
Brief summary
Although arginine vasopressin has been used as an additional drug in refractory shock in worldwide clinical practice, there are no prospective studies using it as a first choice therapy in patients with cancer and septic shock. The aim of this study is assess if the use of arginine vasopressin would be more effective on treatment of septic shock in cancer patients than norepinephrine, decreasing the composite end point of mortality and organ failure in 28 days.
Interventions
DRUGVasopressin
Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement
DRUGNorepinephrine
Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Solid neoplasm needing ICU * Septic Shock according standard criteria
Exclusion criteria
* Younger than 18 years; * Pregnancy; * Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis; * Severe hyponatremia (Na\<130mEq/L); * Acute mesenteric ischemia; * Acute myocardial infarction; * Cardiogenic shock; * Current use of vasopressor before randomization * Expected ICU stay less than 24 hours * Enrolled in another study; * Refusal to consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day mortality | 28-day from randomization | Mortality from all causes in 28-day follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days alive and free of mechanical ventilation | 28 days after randomization | Days alive and free of mechanical ventilation at 28-day follow-up |
| Days alive and free of vasopressors | 28 days after randomization | Days alive and free of any type of vasopressor agent at 28-day follow-up |
| 90-days mortality | 90 days after randomization | Mortality from all causes 90 days after randomization |
| SOFA score in 24 hours | 24 hours after ICU admission | Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 24 hours after randomization. |
| SOFA score in 96 hours | 96 hours after randomization | Severity of organ failure according to the Sequential Organ Failure Assessment (SOFA) score during the first 96 hours after randomization. |
| Days alive and free of renal replacement therapy | 28 days after randomization | requirement of dialysis of hemofiltration at 28-day follow-up |
Countries
Brazil
Outcome results
None listed