Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock

NCT02716597 | Terminated Phase 1 FDA Drug

• 1 other identifier: 14-0727-F2L
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Keywords

albumin, septic shock

Outcome Measures

Primary Outcomes (1)

• Time to Cessation of Vasopressor Therapy

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

  Until ICU Discharge (up to 28 days after study drug administration)

Secondary Outcomes (9)

• Time to Central Line Discontinuation

  Until ICU Discharge (up to 28 days after study drug administration)

• Time on Mechanical Ventilation

  Until ICU Discharge (up to 28 days after study drug administration)

• ICU Mortality

  Until ICU Discharge (up to 28 days after study drug administration)

• ICU Length of Stay

  Until ICU Discharge (up to 28 days after study drug administration)

• Central venous pressure

  Measured hourly until 24 hours following study drug administration

Study Arms (2)

25% Albumin

EXPERIMENTAL

25% albumin 75 grams IV over 1 hour once.

Drug: 25% Albumin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

25% Albumin DRUG

25% Albumin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Vasopressor requirements
• Serum albumin level \<2.5g/dl. The level must be drawn within the last 24 hours of Time=0.

You may not qualify if:

• Patients \<18 years old
• Albumin administration 24 hours prior to the time of enrollment (Time=0)
• Prisoners
• Terminal state
• Known adverse reaction to albumin administration
• Pregnancy
• Pathological conditions in which albumin administration is clinically indicated (hepatic cirrhosis with ascites, hepatorenal syndrome, intestinal malabsorption syndrome, nephrotic syndrome, burns)
• Patients with acute liver failure or cirrhosis
• Patients on continuous renal replacement therapy
• Patients who are morbidly obese ≥40kg/m2
• Religious objection to the administration of human blood products.

Sponsors & Collaborators

• Alexander Flannery, 859-323-4011: lead

Study Sites (1)

University of Kentucky HealthCare Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Albumins

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Alexander H. Flannery, Pharm.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor/PI

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)