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SepsisPhase 4NCT03152474

Adrenal Cortical Function and Vitamin A Deficiency in Sepsis

A Phase 4 study testing Solumedrol 20mg and Vitamin A 100,000 IU in people with Sepsis, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Sepsis
What is being tested?
Solumedrol 20mg and Vitamin A 100,000 IU
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
No sites listed yet
Study dates
Feb 1993to Jan 2000
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sepsis
  • Severe Sepsis
  • Septic Shock

Who cannot join

  • On glucocorticoids
  • On Vitamin A
  • On any active medical research study
  • Failed ACTH stimulation test (All serum cortisol concentrations < 20 mg/dl)

About this study

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

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.

Read the 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.

Conditions
Sepsis
Being tested
Solumedrol 20mg, Vitamin A 100,000 IU, Placebo
Medical subject headings
Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Solumedrol 20mgDrug

    Also called Methylprednisolone Sodium Succinate

    Dosed Intravenous every 8 hrs.

  • Vitamin A 100,000 IUDrug

    Also called Retinol

    Dosed Intramuscular once daily

  • PlaceboOther

    Placebo dosed intravenous every 8 hrs. or Intramuscular once daily.

Study groups in NCT03152474
Study groupRoleWhat they receive
Solumedrol 20mgActive comparatorSolumedrol injection will be given in the vein every 8 hrs. for 7 days.
Receives: Drug: Solumedrol 20mg; Other: Placebo
Vitamin A 100,000 IUActive comparatorVitamin A injection will be given in the arm muscle for 7 days.
Receives: Drug: Vitamin A 100,000 IU; Other: Placebo
PlaceboPlacebo comparatorPlacebo will be given in the vein every 8 hrs. for 7 days or given in the arm muscle for 7 days.
Receives: Drug: Solumedrol 20mg; Drug: Vitamin A 100,000 IU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28 days mortality

    Document the 28 days of mortality

    Measured: 28 days

Secondary outcomes (14)

  1. 14 day mortality

    Mortality at day 14

    Measured: 14 days

  2. Number of Secondary Infections

    Document the number of secondary infections

    Measured: Day 28

  3. Days in ICU

    Document the days in ICU

    Measured: Day 14 and Day 28

  4. Number of days on ventilator

    Document the days on ventilator

    Measured: 28 days

  5. Number of days of ventilator adjusted for mortality

    Document the number of days of ventilator adjusted for mortality

    Measured: 28 days

  6. Number of days on pressor agents

    Document the number of days on pressor agents

    Measured: 28 days

  7. Number of Days on PPI or H2 blockers

    Document the days on PPI or H2 blockers

    Measured: 28 days

  8. Number of days of pressor agents corrected for mortality

    Document the number of days of pressor agents corrected for mortality

    Measured: 28 days

  9. Change in serum albumin concentration

    Document the serum albumin concentration

    Measured: 28 days

  10. New Onset Renal Failure

    Document any new onset renal failure

    Measured: Day 14

  11. Serum vitamin A concentration

    Document levels of serum vitamin A concentration

    Measured: baseline and day 14

  12. Urine Vitamin A Concentration

    Document levels of vitamin A concentration in urine

    Measured: baseline and day 14

  13. APACHE Score

    Calculate and document APACHE score

    Measured: Day 1 and Day 14

  14. ACTH Stimulation Test

    Efficiency of ACTH stimulation test

    Measured: Day 1 and Day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2017
  2. Study startFeb 1993
  3. Primary completionJan 2000
  4. Study completionJan 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double Blind Placebo Controlled
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03152474
Sponsor's protocol ID
7476-01
Other IDs
7680-01, 7681-01, 7682-01
Status last verified
Apr 2017
First submitted
7 Apr 2017
Last updated
16 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only the de-identified study data will be shared with the other researchers.

Publications

  • Cherukuri L, Gewirtz G, Osea K, Tayek JA. Vitamin A treatment for severe sepsis in humans; a prospective randomized double blind placebo-controlled clinical trial. Clin Nutr ESPEN. 2019 Feb;29:49-51. doi: 10.1016/j.clnesp.2018.10.011. Epub 2018 Nov 17.

    PubMed 30661700

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Solumedrol 20mg and Vitamin A 100,000 IU in people with Sepsis, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28 days mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03152474, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.

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