A Phase 3 interventional study of Lactated Ringer and Albumin in Septic Shock and Severe Sepsis, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by University of Sao Paulo · Phase 3, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 360 is above the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Lactated Ringer
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.
Drug: Albumin
Lactated Ringer
Albumin 4%
Mortality in 7 days for any cause
Time frame: day 7
Evaluation of sequential organ failure assessment (SOFA) score
Time frame: from day 1 until day 7 of care in ICU
ICU length of stay
Time frame: day 28
hospital length of stay
Time frame: day 28
ventilator-free days
Time frame: day 28
Needing of renal replacement therapy
Time frame: day 28
days free of vasopressor
Time frame: day 28
Mortality in 28-days
Time frame: 28 days after randomization
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo