Sepsis
Conditions
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.
Interventions
DRUGSolumedrol 20mg
Dosed Intravenous every 8 hrs.
DRUGVitamin A 100,000 IU
Dosed Intramuscular once daily
OTHERPlacebo
Placebo dosed intravenous every 8 hrs. or Intramuscular once daily.
Sponsors
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double Blind (to investigator, subject, hospital care team and study team members except for research pharmacist), Randomized, Placebo Controlled Clinical Trial; Placebos were wrapped in foil and coded to prevent identification of study material.
Intervention model description
Double Blind Placebo Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28 days mortality | 28 days | Document the 28 days of mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Secondary Infections | Day 28 | Document the number of secondary infections |
| 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 |
| Number of Days on PPI or H2 blockers | 28 days | Document the days on PPI or H2 blockers |
| 14 day mortality | 14 days | Mortality at day 14 |
| 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 |
| Number of days of pressor agents corrected for mortality | 28 days | Document the number of days of pressor agents corrected for mortality |
Outcome results
None listed