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Adrenal Cortical Function and Vitamin A Deficiency in Sepsis

Primary Purpose

Sepsis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Solumedrol 20mg
Vitamin A 100,000 IU
Placebo
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Sepsis
  • Severe Sepsis
  • Septic Shock

Exclusion Criteria:

  • On glucocorticoids
  • On Vitamin A
  • On any active medical research study
  • Failed ACTH stimulation test (All serum cortisol concentrations < 20 mg/dl)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Solumedrol 20mg

    Vitamin A 100,000 IU

    Placebo

    Arm Description

    Solumedrol injection will be given in the vein every 8 hrs. for 7 days.

    Vitamin A injection will be given in the arm muscle for 7 days.

    Placebo will be given in the vein every 8 hrs. for 7 days or given in the arm muscle for 7 days.

    Outcomes

    Primary Outcome Measures

    28 days mortality
    Document the 28 days of mortality

    Secondary Outcome Measures

    14 day mortality
    Mortality at day 14
    Number of Secondary Infections
    Document the number of secondary infections
    Days in ICU
    Document the days in ICU
    Number of days on ventilator
    Document the days on ventilator
    Number of days of ventilator adjusted for mortality
    Document the number of days of ventilator adjusted for mortality
    Number of days on pressor agents
    Document the number of days on pressor agents
    Number of Days on PPI or H2 blockers
    Document the days on PPI or H2 blockers
    Number of days of pressor agents corrected for mortality
    Document the number of days of pressor agents corrected for mortality
    Change in serum albumin concentration
    Document the serum albumin concentration
    New Onset Renal Failure
    Document any new onset renal failure
    Serum vitamin A concentration
    Document levels of serum vitamin A concentration
    Urine Vitamin A Concentration
    Document levels of vitamin A concentration in urine
    APACHE Score
    Calculate and document APACHE score
    ACTH Stimulation Test
    Efficiency of ACTH stimulation test

    Full Information

    First Posted
    April 7, 2017
    Last Updated
    May 15, 2017
    Sponsor
    Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03152474
    Brief Title
    Adrenal Cortical Function and Vitamin A Deficiency in Sepsis
    Official Title
    Adrenal Cortical Function and Vitamin A Deficiency in Sepsis, Severe Sepsis and Septic Shock: Prospective Randomized, Double Blind Placebo Controlled Clinical Trials
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1993 (undefined)
    Primary Completion Date
    January 2000 (Actual)
    Study Completion Date
    January 2000 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study involves the participant to receive a 250 mcg Cortrosyn (ACTH) Stimulation Test to test the ability of the body to make Cortisol. If the body is not able to make large amount of Cortisol (Delta Cortisol < 13 mg/dl) from the stimulation test, then the participant will be given additional cortisol like medicine called Solumedrol or matching placebo. If the body is able to make large amounts of Cortisol (> 13 mg/dl), then the participant will receive daily shots of Vitamin A for 7 days or matching placebo. If the participant does not respond to the stimulation test, and meets the criteria for Cortisol deficiency (all 3 cortisol concentrations < 20 mg/dl), then he/she will screen failed for the study and will be offered hydrocortisone as part of routine care by the treating physician.
    Detailed Description
    The eligible patients will have Sepsis, Severe Sepsis or Septic Shock. The potential subject will be approached for the study participation and if agreed will sign an Inform Consent. Patients unable to give consent, a waiver of consent was used. The participant to receive a Cortrosyn Stimulation Test to test the ability of the body to make Cortisol. The Cortrosyn Stimulation Test involves an injection into the vein in the arm. Two tablespoons of blood is collected just before the injection of Cortrosyn (250 mcg of ACTH) and again 30 minutes and 60 minutes after the injection. The results of test are available about 3 hours after the start of the test. Depending on the results of the test, subject will be either screen failed or will either receive Solumedrol or Vitamin A. Also at the beginning of the study, the amount of water in the subject's body will be measured using a machine called Impedance Monitor. If the body is not able to make large amount of Cortisol from the stimulation test (delta increase in cortisol < 13 mg/dl), then the participant will be given additional cortisol like medicine called Solumedrol (20 mg) by injection into a vein every 8 hours for 7 days or matching placebo. If the body is able to make large amounts of Cortisol (delta cortisol response > 13 mg/dL), then the participant will receive daily shots of Vitamin A or matching placebo for 7 days by injection into arm muscle. After 1, 3, 8 and 14 days of the study, a blood draw will performed to measure the amount of Vitamin A in the blood. Also, the urine will be collected to measure Vitamin A levels on day 1, 2, 3, 8 and 14. The ACTH stimulation test was repeated on Day 8. The total amount of blood drawn for the study will be about 18 tablespoons. If the participant does not respond to the stimulation test, and meets the criteria for Cortisol deficiency (All cortisol concentrations < 20 mg/dl) , then he/she will screen failed for the study and will be offered 100 mg of hydrocortisone treatment (100 mg IV every 8 hours) as part of routine care by the treating physician.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Double Blind Placebo Controlled
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    Double Blind (to investigator, subject, hospital care team and study team members except for research pharmacist), Randomized, Placebo Controlled Clinical Trial; Placebos were wrapped in foil and coded to prevent identification of study material.
    Allocation
    Randomized
    Enrollment
    300 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Solumedrol 20mg
    Arm Type
    Active Comparator
    Arm Description
    Solumedrol injection will be given in the vein every 8 hrs. for 7 days.
    Arm Title
    Vitamin A 100,000 IU
    Arm Type
    Active Comparator
    Arm Description
    Vitamin A injection will be given in the arm muscle for 7 days.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo will be given in the vein every 8 hrs. for 7 days or given in the arm muscle for 7 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Solumedrol 20mg
    Other Intervention Name(s)
    Methylprednisolone Sodium Succinate
    Intervention Description
    Dosed Intravenous every 8 hrs.
    Intervention Type
    Drug
    Intervention Name(s)
    Vitamin A 100,000 IU
    Other Intervention Name(s)
    Retinol
    Intervention Description
    Dosed Intramuscular once daily
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo dosed intravenous every 8 hrs. or Intramuscular once daily.
    Primary Outcome Measure Information:
    Title
    28 days mortality
    Description
    Document the 28 days of mortality
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    14 day mortality
    Description
    Mortality at day 14
    Time Frame
    14 days
    Title
    Number of Secondary Infections
    Description
    Document the number of secondary infections
    Time Frame
    Day 28
    Title
    Days in ICU
    Description
    Document the days in ICU
    Time Frame
    Day 14 and Day 28
    Title
    Number of days on ventilator
    Description
    Document the days on ventilator
    Time Frame
    28 days
    Title
    Number of days of ventilator adjusted for mortality
    Description
    Document the number of days of ventilator adjusted for mortality
    Time Frame
    28 days
    Title
    Number of days on pressor agents
    Description
    Document the number of days on pressor agents
    Time Frame
    28 days
    Title
    Number of Days on PPI or H2 blockers
    Description
    Document the days on PPI or H2 blockers
    Time Frame
    28 days
    Title
    Number of days of pressor agents corrected for mortality
    Description
    Document the number of days of pressor agents corrected for mortality
    Time Frame
    28 days
    Title
    Change in serum albumin concentration
    Description
    Document the serum albumin concentration
    Time Frame
    28 days
    Title
    New Onset Renal Failure
    Description
    Document any new onset renal failure
    Time Frame
    Day 14
    Title
    Serum vitamin A concentration
    Description
    Document levels of serum vitamin A concentration
    Time Frame
    baseline and day 14
    Title
    Urine Vitamin A Concentration
    Description
    Document levels of vitamin A concentration in urine
    Time Frame
    baseline and day 14
    Title
    APACHE Score
    Description
    Calculate and document APACHE score
    Time Frame
    Day 1 and Day 14
    Title
    ACTH Stimulation Test
    Description
    Efficiency of ACTH stimulation test
    Time Frame
    Day 1 and Day 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sepsis Severe Sepsis Septic Shock Exclusion Criteria: On glucocorticoids On Vitamin A On any active medical research study Failed ACTH stimulation test (All serum cortisol concentrations < 20 mg/dl)

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Only the de-identified study data will be shared with the other researchers.
    Citations:
    PubMed Identifier
    30661700
    Citation
    Cherukuri L, Gewirtz G, Osea K, Tayek JA. Vitamin A treatment for severe sepsis in humans; a prospective randomized double blind placebo-controlled clinical trial. Clin Nutr ESPEN. 2019 Feb;29:49-51. doi: 10.1016/j.clnesp.2018.10.011. Epub 2018 Nov 17.
    Results Reference
    derived

    Learn more about this trial

    Adrenal Cortical Function and Vitamin A Deficiency in Sepsis

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