Adrenal Cortical Function and Vitamin A Deficiency in Sepsis, Severe Sepsis and Septic Shock: Prospective Randomized, Double Blind Placebo Controlled Clinical Trials
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- 28 days mortality
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe Sepsis
- •Septic Shock
排除标准
- •On glucocorticoids
- •On Vitamin A
- •On any active medical research study
- •Failed ACTH stimulation test (All serum cortisol concentrations < 20 mg/dl)
研究组 & 干预措施
Solumedrol 20mg
Solumedrol injection will be given in the vein every 8 hrs. for 7 days.
干预措施: Solumedrol 20mg (Drug)
Solumedrol 20mg
Solumedrol injection will be given in the vein every 8 hrs. for 7 days.
干预措施: Placebo (Other)
Vitamin A 100,000 IU
Vitamin A injection will be given in the arm muscle for 7 days.
干预措施: Vitamin A 100,000 IU (Drug)
Vitamin A 100,000 IU
Vitamin A injection will be given in the arm muscle for 7 days.
干预措施: Placebo (Other)
Placebo
Placebo will be given in the vein every 8 hrs. for 7 days or given in the arm muscle for 7 days.
干预措施: Solumedrol 20mg (Drug)
Placebo
Placebo will be given in the vein every 8 hrs. for 7 days or given in the arm muscle for 7 days.
干预措施: Vitamin A 100,000 IU (Drug)
结局指标
主要结局
28 days mortality
时间窗: 28 days
Document the 28 days of mortality
次要结局
- 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)
- Number of days on pressor agents(28 days)
- Number of Days on PPI or H2 blockers(28 days)
- Number of days of pressor agents corrected for mortality(28 days)
- Change in serum albumin concentration(28 days)
- New Onset Renal Failure(Day 14)
- Serum vitamin A concentration(baseline and day 14)
- Urine Vitamin A Concentration(baseline and day 14)
- APACHE Score(Day 1 and Day 14)
- ACTH Stimulation Test(Day 1 and Day 8)