Septic Shock, Severe Sepsis
Conditions
Keywords
Septic shock, Sepsis, Albumin, Lactated Ringer
Brief summary
The use of albumin in critical ill patients is a matter of controversy. A large randomized controlled trial reported that albumin was as safe and effective as crystalloid solution for fluid replacement in intensive care unit, although the last one was less expensive. In Surviving Sepsis Campaign International Guidelines there are no preference for crystalloids over colloids. But recently, a retrospective analysis of patients with severe sepsis from SAFE study reported that the use of albumin in these patients would be superior, regarding reduction of mortality. The aim of this study is determine whether the use of albumin improve clinical outcomes in patients with severe sepsis or septic shock.
Interventions
DRUGLactated Ringer
Lactated Ringer
DRUGAlbumin
Albumin 4%
Sponsors
University of Sao 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
* Age equal or higher than 18 years-old * Severe sepsis or septic shock into 6 hours of evolution * Written informed consent
Exclusion criteria
* Shock from other causes * Adverse reactions to human albumin * Previous fluid resuscitation during current disease * Previous use of albumin in the last 72 hours * Religion objection * Enrollment in another study * Traumatic brain injury * Hepatic cirrhosis * End stage renal disease * Plasmapheresis * End of life patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality in 7 days for any cause | day 7 |
Secondary
| Measure | Time frame |
|---|---|
| ICU length of stay | day 28 |
| hospital length of stay | day 28 |
| ventilator-free days | day 28 |
| Evaluation of sequential organ failure assessment (SOFA) score | from day 1 until day 7 of care in ICU |
| days free of vasopressor | day 28 |
| Mortality in 28-days | 28 days after randomization |
| Needing of renal replacement therapy | day 28 |
Countries
Brazil
Outcome results
None listed