drugset / Trial / NCT03152474

Adrenal Cortical Function and Vitamin A Deficiency in Sepsis

NCT03152474

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
1993-02
Primary completion
2000-01
Completion
2000-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylprednisolone Other / unclassified 20 mg Intravenous
Comparator Vitamin A Unknown 100000 iu Intramuscular