Severe infection in the intensive care unit is common accounting for about 10% of admissions
and has a death rate of approximately 40-50%. It is almost always associated with significant
reductions in blood pressure. Administration of fluid often in large volumes is essential to
normalize blood pressure and prevent failure of organs and death. Two common classes of fluid
solutions are crystalloid fluids (salt based, normal saline) and colloid fluids (protein
based, albumin). Due to its properties, the albumin fluid may remain in the vascular space
better than the normal saline solution. Hence, there may be faster attainment of normal blood
pressure as well as a reduction in failed organs and death. Preliminary clinical trial data
suggests a potential for benefit with albumin in this setting but these findings require
confirmation in a large clinical trial.
There are few data to explain how albumin may exert its protective effects and lead to better
outcomes for patients with severe infections. We will conduct a clinical study that will
examine potential biological mechanisms for albumin's protective effects in 50 patients
across 6 Canadian academic hospitals. We will also examine our ability to successfully
recruit patients into this trial.
This study will provide information that will help to understand the biological mechanisms of
albumin in severe infection. The information gained will guide the investigative team for
future fluid related mechanistic questions. The study will also provide essential information
that will aid in the design and conduct of the future large clinical trial that will examine
death as its primary outcome.
Phase:
Phase 2
Details
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborators:
Baxter Healthcare Corporation Canadian Blood Services