Clinical Trial: Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock

Brief 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.

Detailed Summary:
Sponsor: Alexander Flannery, 859-323-4011

Current Primary Outcome: Time to Cessation of Vasopressor Therapy [ Time Frame: Until ICU Discharge (up to 28 days after study drug administration) ]

Time from study drug administration to when the patient no longer requires vasopressor support


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to Central Line Discontinuation [ Time Frame: Until ICU Discharge (up to 28 days after study drug administration) ]
    Time from study drug administration to discontinuation of a patient's central line
  • Time on Mechanical Ventilation [ Time Frame: Until ICU Discharge (up to 28 days after study drug administration) ]
    Time the patient requires mechanical ventilation during their ICU stay
  • ICU Mortality [ Time Frame: Until ICU Discharge (up to 28 days after study drug administration) ]
  • ICU Length of Stay [ Time Frame: Until ICU Discharge (up to 28 days after study drug administration) ]
    How long the patient is in the intensive care unit
  • Central venous pressure [ Time Frame: Measured hourly until 24 hours following study drug administration ]
    The central venous pressure (in mm Hg) will be measured hourly from a central line until 24 hours following study drug administration.
  • Heart Rate [ Time Frame: Measured hourly until 24 hours following study drug administration ]
    The heart rate will be measured hourly until 24 hours following study drug administration.
  • Mean arterial pressure [ Time Frame: Measured hourly until 24 hours following study drug administration ]
    The mean arterial pressure (in mm Hg) will be measured hourly from an arterial line until 24 hours following study drug administration.
  • Serum creatinine [ Time Frame: Measured the day following study drug administration ]
    Serum creatinine will be measured with AM labs the day following study drug administration and compared with baseline.
  • Urine output [ Time Frame: Measured for 24 hours following study drug administration ]
    Urine output (in mL) will be measured as part of routine care and totaled for the 24 hour urine output since study drug administration.


Original Secondary Outcome: Same as current

Information By: University of Kentucky

Dates:
Date Received: February 19, 2016
Date Started: March 2016
Date Completion:
Last Updated: September 6, 2016
Last Verified: September 2016