Adrenal Cortical Function and Vitamin A Deficiency in Sepsis

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Status and phase: Completed; Phase 4

Conditions: Sepsis

Treatments: Drug: Vitamin A 100,000 IU; Other: Placebo; Drug: Solumedrol 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03152474

7682-01 (Other Identifier)

7476-01

7680-01 (Other Identifier)

7681-01 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 3 patient groups, including a placebo group

Solumedrol 20mg

Active Comparator group

Description:

Solumedrol injection will be given in the vein every 8 hrs. for 7 days.

Treatment:

Drug: Solumedrol 20mg

Other: Placebo

Vitamin A 100,000 IU

Active Comparator group

Description:

Vitamin A injection will be given in the arm muscle for 7 days.

Treatment:

Drug: Vitamin A 100,000 IU

Other: Placebo

Placebo

Placebo Comparator group

Description:

Placebo will be given in the vein every 8 hrs. for 7 days or given in the arm muscle for 7 days.

Treatment:

Drug: Solumedrol 20mg

Drug: Vitamin A 100,000 IU