A Phase 4 interventional study of Solumedrol 20mg and Vitamin A 100,000 IU in Sepsis, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Solumedrol injection will be given in the vein every 8 hrs. for 7 days.
Drug: Solumedrol 20mg · Other: Placebo
Vitamin A injection will be given in the arm muscle for 7 days.
Drug: Vitamin A 100,000 IU · Other: Placebo
Placebo will be given in the vein every 8 hrs. for 7 days or given in the arm muscle for 7 days.
Drug: Solumedrol 20mg · Drug: Vitamin A 100,000 IU
Dosed Intravenous every 8 hrs.
Also known as: Methylprednisolone Sodium Succinate
Dosed Intramuscular once daily
Also known as: Retinol
Placebo dosed intravenous every 8 hrs. or Intramuscular once daily.
28 days mortality
Document the 28 days of mortality
Time frame: 28 days
14 day mortality
Mortality at day 14
Time frame: 14 days
Number of Secondary Infections
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Time frame: Day 28
Days in ICU
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Time frame: Day 14 and Day 28
Number of days on ventilator
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Time frame: 28 days
Number of days of ventilator adjusted for mortality
Document the number of days of ventilator adjusted for mortality
Time frame: 28 days
Number of days on pressor agents
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Time frame: 28 days
Number of Days on PPI or H2 blockers
Document the days on PPI or H2 blockers
Time frame: 28 days
Number of days of pressor agents corrected for mortality
Document the number of days of pressor agents corrected for mortality
Time frame: 28 days
Change in serum albumin concentration
Document the serum albumin concentration
Time frame: 28 days
New Onset Renal Failure
Document any new onset renal failure
Time frame: Day 14
Serum vitamin A concentration
Document levels of serum vitamin A concentration
Time frame: baseline and day 14
Urine Vitamin A Concentration
Document levels of vitamin A concentration in urine
Time frame: baseline and day 14
APACHE Score
Calculate and document APACHE score
Time frame: Day 1 and Day 14
ACTH Stimulation Test
Efficiency of ACTH stimulation test
Time frame: Day 1 and Day 8
No study locations are listed for this record.
Plan to share: Yes — Only the de-identified study data will be shared with the other researchers.
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center