Adrenal Cortical Function and Vitamin A Deficiency in Sepsis

Sepsis Clinical Trial

Official title:

Adrenal Cortical Function and Vitamin A Deficiency in Sepsis, Severe Sepsis and Septic Shock: Prospective Randomized, Double Blind Placebo Controlled Clinical Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152474
• Other study ID #: 7476-01
• Secondary ID: 7680-017681-0176
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2017
• Last updated: May 15, 2017
• Start date: February 1993
• Est. completion date: January 2000

Study information

• Verified date: April 2017
• Source: Los Angeles Biomedical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2000
• Est. primary completion date: January 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Night Blindness
• Sepsis
• Toxemia
• Vitamin A Deficiency

Intervention

Drug:
• Solumedrol 20mg
Dosed Intravenous every 8 hrs.
• Vitamin A 100,000 IU
Dosed Intramuscular once daily

Other:
• Placebo
Placebo dosed intravenous every 8 hrs. or Intramuscular once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Los Angeles Biomedical Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28 days mortality	Document the 28 days of mortality	28 days
Secondary	14 day mortality	Mortality at day 14	14 days
Secondary	Number of Secondary Infections	Document the number of secondary infections	Day 28
Secondary	Days in ICU	Document the days in ICU	Day 14 and Day 28
Secondary	Number of days on ventilator	Document the days on ventilator	28 days
Secondary	Number of days of ventilator adjusted for mortality	Document the number of days of ventilator adjusted for mortality	28 days
Secondary	Number of days on pressor agents	Document the number of days on pressor agents	28 days
Secondary	Number of Days on PPI or H2 blockers	Document the days on PPI or H2 blockers	28 days
Secondary	Number of days of pressor agents corrected for mortality	Document the number of days of pressor agents corrected for mortality	28 days
Secondary	Change in serum albumin concentration	Document the serum albumin concentration	28 days
Secondary	New Onset Renal Failure	Document any new onset renal failure	Day 14
Secondary	Serum vitamin A concentration	Document levels of serum vitamin A concentration	baseline and day 14
Secondary	Urine Vitamin A Concentration	Document levels of vitamin A concentration in urine	baseline and day 14
Secondary	APACHE Score	Calculate and document APACHE score	Day 1 and Day 14
Secondary	ACTH Stimulation Test	Efficiency of ACTH stimulation test	Day 1 and Day 8