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Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02716597
Recruitment Status : Terminated (difficulty enrolling)
First Posted : March 23, 2016
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Alexander Flannery, 859-323-4011, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Shock, Septic Drug: 25% Albumin Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock
Study Start Date : March 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: 25% Albumin
25% albumin 75 grams IV over 1 hour once.
Drug: 25% Albumin
Placebo Comparator: Placebo
0.9% normal saline 200mL IV over 1 hour once.
Drug: Placebo



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. ICU Mortality [ Time Frame: Until ICU Discharge (up to 28 days after study drug administration) ]
  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716597


Locations
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United States, Kentucky
University of Kentucky HealthCare Chandler Medical Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Alexander Flannery, 859-323-4011
Investigators
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Principal Investigator: Alexander H. Flannery, Pharm.D. University of Kentucky
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Responsible Party: Alexander Flannery, 859-323-4011, Sponsor/PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT02716597    
Other Study ID Numbers: 14-0727-F2L
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alexander Flannery, 859-323-4011, University of Kentucky:
albumin, septic shock
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation