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Adrenal Cortical Function and Vitamin A Deficiency in Sepsis

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ClinicalTrials.gov Identifier: NCT03152474
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute

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.


Condition or disease Intervention/treatment Phase
Sepsis Drug: Solumedrol 20mg Drug: Vitamin A 100,000 IU Other: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double Blind Placebo Controlled
Masking: Triple (Participant, Care Provider, Investigator)
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.
Primary Purpose: Treatment
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 Start Date : February 1993
Actual Primary Completion Date : January 2000
Actual Study Completion Date : January 2000


Arm Intervention/treatment
Active Comparator: Solumedrol 20mg
Solumedrol injection will be given in the vein every 8 hrs. for 7 days.
Drug: Solumedrol 20mg
Dosed Intravenous every 8 hrs.
Other Name: Methylprednisolone Sodium Succinate

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

Active Comparator: Vitamin A 100,000 IU
Vitamin A injection will be given in the arm muscle for 7 days.
Drug: Vitamin A 100,000 IU
Dosed Intramuscular once daily
Other Name: Retinol

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

Placebo Comparator: Placebo
Placebo will be given in the vein every 8 hrs. for 7 days or given in the arm muscle for 7 days.
Drug: Solumedrol 20mg
Dosed Intravenous every 8 hrs.
Other Name: Methylprednisolone Sodium Succinate

Drug: Vitamin A 100,000 IU
Dosed Intramuscular once daily
Other Name: Retinol




Primary Outcome Measures :
  1. 28 days mortality [ Time Frame: 28 days ]
    Document the 28 days of mortality


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT03152474     History of Changes
Other Study ID Numbers: 7476-01
7680-01 ( Other Identifier: Los Angeles Biomedical Research Institute )
7681-01 ( Other Identifier: Los Angeles Biomedical Research Institute )
7682-01 ( Other Identifier: Los Angeles Biomedical Research Institute )
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Only the de-identified study data will be shared with the other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitamin A Deficiency
Night Blindness
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone Acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics