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Shock, SepticPhase 1NCT02716597

Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock

A Phase 1 study testing 25% Albumin in people with Shock, Septic, run by Alexander Flannery, 859-323-4011 at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shock, Septic
What is being tested?
25% Albumin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
11 participants
Where
1 siteUnited States
Study dates
Mar 2016to Jan 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older who meet the clinical criteria for septic shock
  • 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%.
  • 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
  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kentucky HealthCare Chandler Medical Center

    Lexington, Kentucky, 40536

Other trials in United States

About this study

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
Being tested
25% Albumin, Placebo
Keywords
albumin, septic shock
Medical subject headings
Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 25% AlbuminDrug

  • PlaceboDrug

Study groups in NCT02716597
Study groupRoleWhat they receive
25% AlbuminExperimental25% albumin 75 grams IV over 1 hour once.
Receives: Drug: 25% Albumin
PlaceboPlacebo comparator0.9% normal saline 200mL IV over 1 hour once.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Cessation of Vasopressor Therapy

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

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

Secondary outcomes (9)

  1. Time to Central Line Discontinuation

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

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

  2. Time on Mechanical Ventilation

    Time the patient requires mechanical ventilation during their ICU stay

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

  3. ICU Mortality

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

  4. ICU Length of Stay

    How long the patient is in the intensive care unit

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

  5. 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.

    Measured: Measured hourly until 24 hours following study drug administration

  6. Heart Rate

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

    Measured: Measured hourly until 24 hours following study drug administration

  7. 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.

    Measured: Measured hourly until 24 hours following study drug administration

  8. Serum creatinine

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

    Measured: Measured the day following study drug administration

  9. 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.

    Measured: Measured for 24 hours following study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionJan 2019
  4. Study completionJan 2019

Why it stopped: difficulty enrolling

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02716597
Sponsor's protocol ID
14-0727-F2L
Status last verified
Apr 2019
First submitted
19 Feb 2016
Last updated
4 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 25% Albumin in people with Shock, Septic, run by Alexander Flannery, 859-323-4011 at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: difficulty enrolling). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Cessation of Vasopressor Therapy (time frame: Until ICU Discharge (up to 28 days after study drug administration)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02716597.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.

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