Lactated Ringer Versus Albumin in Early Sepsis Therapy
- Registration Number
- NCT01337934
- Lead Sponsor
- University of Sao Paulo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
- Age equal or higher than 18 years-old
- Severe sepsis or septic shock into 6 hours of evolution
- Written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Albumin 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. Lactated Ringer 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.
- Primary Outcome Measures
Name Time Method Mortality in 7 days for any cause day 7
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Cancer Institute of Sao Paulo, School of Medicine, University of Sao Paulo
🇧🇷Sao Paulo, Sao Paulo/SP, Brazil