Adrenal Cortical Function and Vitamin A Deficiency in Sepsis

NCT03152474 | Completed Phase 4

• 4 other identifiers: 7476-017680-017681-017682-01
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• 28 days mortality

  Document the 28 days of mortality

  28 days

Secondary Outcomes (14)

• 14 day mortality

  14 days

• Number of Secondary Infections

  Day 28

• Days in ICU

  Day 14 and Day 28

• Number of days on ventilator

  28 days

• Number of days of ventilator adjusted for mortality

  28 days

Study Arms (3)

Solumedrol 20mg

ACTIVE COMPARATOR

Solumedrol injection will be given in the vein every 8 hrs. for 7 days.

Drug: Solumedrol 20mg; Other: Placebo

Vitamin A 100,000 IU

ACTIVE COMPARATOR

Vitamin A injection will be given in the arm muscle for 7 days.

Drug: Vitamin A 100,000 IU; Other: Placebo

Placebo

PLACEBO COMPARATOR

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

Interventions

Solumedrol 20mg DRUG

Dosed Intravenous every 8 hrs.

Also known as: Methylprednisolone Sodium Succinate

Placebo; Solumedrol 20mg

Vitamin A 100,000 IU DRUG

Dosed Intramuscular once daily

Also known as: Retinol

Placebo; Vitamin A 100,000 IU

Placebo OTHER

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

Solumedrol 20mg; Vitamin A 100,000 IU

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sepsis
• Severe Sepsis
• Septic Shock

You may not qualify if:

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

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead

Related Publications (1)

• 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.

  PMID: 30661700 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Methylprednisolone Hemisuccinate; Vitamin A

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double Blind Placebo Controlled

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: May 15, 2017
• Study Start: February 1, 1993
• Primary Completion: January 1, 2000
• Study Completion: January 1, 2000
• Last Updated: May 16, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share