Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock

Phase 1

Terminated

• Conditions: Shock, Septic
• Interventions: Drug: Placebo; Drug: 25% Albumin

• Registration Number: NCT02716597
• Lead Sponsor: Alexander Flannery, 859-323-4011

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-02-19
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-23
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	0.9% normal saline 200mL IV over 1 hour once.
25% Albumin	25% Albumin	25% albumin 75 grams IV over 1 hour once.

Primary Outcome Measures

Name	Time	Method
Time to Cessation of Vasopressor Therapy	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

Name	Time	Method
Time to Central Line Discontinuation	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	Until ICU Discharge (up to 28 days after study drug administration)	Time the patient requires mechanical ventilation during their ICU stay
ICU Length of Stay	Until ICU Discharge (up to 28 days after study drug administration)	How long the patient is in the intensive care unit
Heart Rate	Measured hourly until 24 hours following study drug administration	The heart rate will be measured hourly until 24 hours following study drug administration.
ICU Mortality	Until ICU Discharge (up to 28 days after study drug administration)
Central venous pressure	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.
Mean arterial pressure	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	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	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.

Trial Locations

Locations (1)

University of Kentucky HealthCare Chandler Medical Center; 🇺🇸 Lexington, Kentucky, United States