Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock

NCT ID: NCT02716597

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-01-31

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.

Conditions

Shock, Septic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

25% Albumin

25% albumin 75 grams IV over 1 hour once.

Group Type: EXPERIMENTAL

25% Albumin

Intervention Type: DRUG

Placebo

0.9% normal saline 200mL IV over 1 hour once.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

25% Albumin

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexander Flannery, 859-323-4011

OTHER

Sponsor Role: lead

Responsible Party

Alexander Flannery, 859-323-4011

Sponsor/PI

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Alexander H. Flannery, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky HealthCare Chandler Medical Center

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

14-0727-F2L

Identifier Type: -

Identifier Source: org_study_id