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Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock

Primary Purpose

Shock, Septic

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

25% Albumin

Placebo

About this trial

This is an interventional supportive care trial for Shock, Septic focused on measuring albumin, septic shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

University of Kentucky HealthCare Chandler Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

25% Albumin

Placebo

Arm Description

25% albumin 75 grams IV over 1 hour once.

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

Outcomes

Primary Outcome Measures

Time to Cessation of Vasopressor Therapy

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

Secondary Outcome Measures

Time to Central Line Discontinuation

Time from study drug administration to discontinuation of a patient's central line

Time on Mechanical Ventilation

Time the patient requires mechanical ventilation during their ICU stay

ICU Mortality

ICU Length of Stay

How long the patient is in the intensive care unit

Central venous pressure

The central venous pressure (in mm Hg) will be measured hourly from a central line until 24 hours following study drug administration.

Heart Rate

The heart rate will be measured hourly until 24 hours following study drug administration.

Mean arterial pressure

The mean arterial pressure (in mm Hg) will be measured hourly from an arterial line until 24 hours following study drug administration.

Serum creatinine

Serum creatinine will be measured with AM labs the day following study drug administration and compared with baseline.

Urine output

Urine output (in mL) will be measured as part of routine care and totaled for the 24 hour urine output since study drug administration.

Full Information

NCT ID

NCT02716597

First Posted

February 19, 2016

Last Updated

April 2, 2019

Sponsor

Alexander Flannery, 859-323-4011

1. Study Identification

Unique Protocol Identification Number

NCT02716597

Brief Title

Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock

Official Title

Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Why Stopped

difficulty enrolling

Study Start Date

March 2016 (undefined)

Primary Completion Date

January 2019 (Actual)

Study Completion Date

January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Alexander Flannery, 859-323-4011

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shock, Septic

Keywords

albumin, septic shock

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

25% Albumin

Arm Type

Experimental

Arm Description

25% albumin 75 grams IV over 1 hour once.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

25% Albumin

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Time to Cessation of Vasopressor Therapy

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Time to Central Line Discontinuation

Description

Time from study drug administration to discontinuation of a patient's central line

Time Frame

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

Title

Time on Mechanical Ventilation

Description

Time the patient requires mechanical ventilation during their ICU stay

Time Frame

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

Title

ICU Mortality

Time Frame

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

Title

ICU Length of Stay

Description

How long the patient is in the intensive care unit

Time Frame

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

Title

Central venous pressure

Description

The central venous pressure (in mm Hg) will be measured hourly from a central line until 24 hours following study drug administration.

Time Frame

Measured hourly until 24 hours following study drug administration

Title

Heart Rate

Description

The heart rate will be measured hourly until 24 hours following study drug administration.

Time Frame

Measured hourly until 24 hours following study drug administration

Title

Mean arterial pressure

Description

The mean arterial pressure (in mm Hg) will be measured hourly from an arterial line until 24 hours following study drug administration.

Time Frame

Measured hourly until 24 hours following study drug administration

Title

Serum creatinine

Description

Serum creatinine will be measured with AM labs the day following study drug administration and compared with baseline.

Time Frame

Measured the day following study drug administration

Title

Urine output

Description

Urine output (in mL) will be measured as part of routine care and totaled for the 24 hour urine output since study drug administration.

Time Frame

Measured for 24 hours following study drug administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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. Serum albumin level <2.5g/dl. The level must be drawn within the last 24 hours of Time=0. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander H. Flannery, Pharm.D.

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky HealthCare Chandler Medical Center

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock

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