Overview

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)