Ringer Versus Albumin In Septic Patients: a Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Mortality in 7 days for any cause
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Lactated Ringer
Patients randomized for this group will receive 500 ml of lactated Ringer solution in early phase of sepsis or septic shock (less than six hour from sepsis onset) if mean arterial pressure was under 65mmHg, or blood lactate concentration higher than 4 mmol/L or base excess under - 4mmol/L until the target of central venous pressure of 8 mmHg or higher or recovery of hypotension.
Intervention: Lactated Ringer (Drug)
Albumin
Patients randomized for Albumin group will receive 500 ml of 4% Albumin solution in early phase of sepsis (less than six hour from sepsis onset) if mean arterial pressure was under 65mmHg or blood lactate concentration higher than 4 mmol/L or base excess under - 4mmol/L until the target of central venous pressure of 8 mmHg or higher or recovery of hypotension.
Intervention: Albumin (Drug)
Outcomes
Primary Outcomes
Mortality in 7 days for any cause
Time Frame: day 7
Secondary Outcomes
- hospital length of stay(day 28)
- ICU length of stay(day 28)
- days free of vasopressor(day 28)
- Mortality in 28-days(28 days after randomization)
- Evaluation of sequential organ failure assessment (SOFA) score(from day 1 until day 7 of care in ICU)
- ventilator-free days(day 28)
- Needing of renal replacement therapy(day 28)
Investigators
Juliano P Almeida, MD, PhD
Instituto do Cancer do Estado de Sao Paulo
University of Sao Paulo