NCT02716597

Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Alexander Flannery, 859-323-4011 · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The role of albumin in sepsis has been controversial for decades. Although hypoalbuminemia has been associated with worse outcomes in sepsis, definitive evidence does not exist that replacing albumin in these patients improves outcomes. However, subgroup analyses from large clinical trials indicate that albumin may reduce mortality in septic shock, and in particular, may reduce the time a patient requires vasopressor support. Given this background, we are conducting this study to evaluate the role of albumin replacement in the patient with resolving septic shock to determine if albumin administration reduces the time a patient requires vasopressor support, reduces the time required for central line, and ultimately whether any potential benefit in terms of reduction of vasopressor support is associated with ICU length of stay and other outcomes. The approach is unique from larger trials of albumin in that it is a septic shock study geared at a particular phenotype of the patient in septic shock and evaluating a specific intervention at a specific time point in the course of septic shock.

Conditions

• Shock, Septic

Interventions

Type	Name	Description
DRUG	25% Albumin
DRUG	Placebo

Timeline

• Start date: 2016-03-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2016-03-23
• Last updated: 2019-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study