Adrenal Cortical Function and Vitamin A Deficiency in Sepsis

• Status: Completed
• Trial end date: 2000-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Los Angeles Biomedical Research Institute; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Retinol palmitate; Vitamin A; Vitamins

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)