Adrenal Cortical Function and Vitamin A Deficiency in Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia; Night Blindness; Vitamin A Deficiency
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Solumedrol 20mg; Vitamin A 100,000 IU; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Dosed Intravenous every 8 hrs.; Dosed Intramuscular once daily; Placebo dosed intravenous every 8 hrs. or Intramuscular once daily.
Other intervention name(s): Methylprednisolone Sodium Succinate; Retinol
Intervention MeSH terms: Vitamin A; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double Blind Placebo Controlled
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment