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Completed

NCT Number: NCT03152474

Adrenal Cortical Function and Vitamin A Deficiency in Sepsis

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Solumedrol 20mg

Drug

Dosed Intravenous every 8 hrs.

Other names: Methylprednisolone Sodium Succinate

Vitamin A 100,000 IU

Drug

Dosed Intramuscular once daily

Other names: Retinol

Placebo

Other

Placebo dosed intravenous every 8 hrs. or Intramuscular once daily.

Primary outcomes

  1. 28 days mortality

    Time frame: 28 days

    Document the 28 days of mortality

Secondary outcomes

  1. 14 day mortality

    Time frame: 14 days

    Mortality at day 14

  2. Number of Secondary Infections

    Time frame: Day 28

    Document the number of secondary infections

  3. Days in ICU

    Time frame: Day 14 and Day 28

    Document the days in ICU

  4. Number of days on ventilator

    Time frame: 28 days

    Document the days on ventilator

  5. Number of days of ventilator adjusted for mortality

    Time frame: 28 days

    Document the number of days of ventilator adjusted for mortality

  6. Number of days on pressor agents

    Time frame: 28 days

    Document the number of days on pressor agents

  7. Number of Days on PPI or H2 blockers

    Time frame: 28 days

    Document the days on PPI or H2 blockers

  8. Number of days of pressor agents corrected for mortality

    Time frame: 28 days

    Document the number of days of pressor agents corrected for mortality

  9. Change in serum albumin concentration

    Time frame: 28 days

    Document the serum albumin concentration

  10. New Onset Renal Failure

    Time frame: Day 14

    Document any new onset renal failure

  11. Serum vitamin A concentration

    Time frame: baseline and day 14

    Document levels of serum vitamin A concentration

  12. Urine Vitamin A Concentration

    Time frame: baseline and day 14

    Document levels of vitamin A concentration in urine

  13. APACHE Score

    Time frame: Day 1 and Day 14

    Calculate and document APACHE score

  14. ACTH Stimulation Test

    Time frame: Day 1 and Day 8

    Efficiency of ACTH stimulation test

Sponsors and collaborators

Lead sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Other

Registry information

Official study title

Adrenal Cortical Function and Vitamin A Deficiency in Sepsis, Severe Sepsis and Septic Shock: Prospective Randomized, Double Blind Placebo Controlled Clinical Trials

Important dates

Study start
1993
Primary completion
2000
Study completion
2000
First posted
May 15, 2017
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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