Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock
| Status: | Terminated |
|---|---|
| Conditions: | Hospital, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | March 2016 |
| End Date: | January 2019 |
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.
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.
Inclusion Criteria:
1. 18 years of age or older who meet the clinical criteria for septic shock
a. Presence of two or more of the following: i. A core temp ≥38C or ≤36C; ii. A heart
rate ≥90 beats/min; iii. A respiratory rate ≥ 20 breaths/min or PaCO2 ≤32mmHg or use
of mechanical ventilation for an acute process; iv. A white blood cell count ≥12000/ml
or ≤4000/ml or immature neutrophils > 10%.
b. Presence of defined (or suspected) site of infection as show by at least one of the
following criteria: i. An organism grown in blood or sterile site; ii. An abscess or
portion of infected tissue; iii. Suspected infection despite culture growth by the
attending physician. c. Infusion of vasopressors is required to maintain blood
pressure
2. Vasopressor requirements
a. Patients can be considered for study inclusion when his/her vasopressor
requirements are as follows: i. Norepinephrine 0.04-0.25 mcg/kg/min (plus or minus
vasopressin) OR phenylephrine 0.2-2 mcg/kg/min (plus or minus vasopressin) AND ii.
Last measured lactate value was < 4 mmol/L AND iii. The patient is on stable or
decreasing doses of vasopressors for 8 hours or more. This 8 hour measurement will
start at the maximum amount of vasopressor support within the range defined in i.
above.
3. Serum albumin level <2.5g/dl. The level must be drawn within the last 24 hours of
Time=0.
Exclusion Criteria:
1. Patients <18 years old
2. Albumin administration 24 hours prior to the time of enrollment (Time=0)
3. Prisoners
4. Terminal state
5. Known adverse reaction to albumin administration
6. Pregnancy
7. Pathological conditions in which albumin administration is clinically indicated
(hepatic cirrhosis with ascites, hepatorenal syndrome, intestinal malabsorption
syndrome, nephrotic syndrome, burns)
8. Patients with acute liver failure or cirrhosis
9. Patients on continuous renal replacement therapy
10. Patients who are morbidly obese ≥40kg/m2
11. Religious objection to the administration of human blood products.
We found this trial at
1
site
Lexington, Kentucky 40536
Phone: 859-323-9078
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