Adrenal Cortical Function and Vitamin A Deficiency in Sepsis
- Conditions
- Sepsis
- Interventions
- Drug: Solumedrol 20mgDrug: Vitamin A 100,000 IUOther: Placebo
- Registration Number
- NCT03152474
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- Sepsis
- Severe Sepsis
- Septic Shock
- On glucocorticoids
- On Vitamin A
- On any active medical research study
- Failed ACTH stimulation test (All serum cortisol concentrations < 20 mg/dl)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Solumedrol 20mg Solumedrol 20mg Solumedrol injection will be given in the vein every 8 hrs. for 7 days. Solumedrol 20mg Placebo Solumedrol injection will be given in the vein every 8 hrs. for 7 days. Vitamin A 100,000 IU Vitamin A 100,000 IU Vitamin A injection will be given in the arm muscle for 7 days. Vitamin A 100,000 IU Placebo Vitamin A injection will be given in the arm muscle for 7 days. Placebo Solumedrol 20mg Placebo will be given in the vein every 8 hrs. for 7 days or given in the arm muscle for 7 days. Placebo Vitamin A 100,000 IU Placebo will be given in the vein every 8 hrs. for 7 days or given in the arm muscle for 7 days.
- Primary Outcome Measures
Name Time Method 28 days mortality 28 days Document the 28 days of mortality
- Secondary Outcome Measures
Name Time Method Days in ICU Day 14 and Day 28 Document the days in ICU
Number of days on ventilator 28 days Document the days on ventilator
Number of days of ventilator adjusted for mortality 28 days Document the number of days of ventilator adjusted for mortality
Number of days on pressor agents 28 days Document the number of days on pressor agents
14 day mortality 14 days Mortality at day 14
Number of Secondary Infections Day 28 Document the number of secondary infections
Number of Days on PPI or H2 blockers 28 days Document the days on PPI or H2 blockers
Number of days of pressor agents corrected for mortality 28 days Document the number of days of pressor agents corrected for mortality
Change in serum albumin concentration 28 days Document the serum albumin concentration
New Onset Renal Failure Day 14 Document any new onset renal failure
Serum vitamin A concentration baseline and day 14 Document levels of serum vitamin A concentration
Urine Vitamin A Concentration baseline and day 14 Document levels of vitamin A concentration in urine
APACHE Score Day 1 and Day 14 Calculate and document APACHE score
ACTH Stimulation Test Day 1 and Day 8 Efficiency of ACTH stimulation test