Adrenal Cortical Function and Vitamin A Deficiency in Sepsis
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.
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.
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)