Thiamine as a Renal Protective Agent in Septic Shock: A Randomized, Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 4
- 主要终点
- Kidney Injury Biomarker
研究概览
简要总结
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal function in septic shock.
详细描述
This is a randomized, double-blind, placebo controlled study to investigate the effect of intravenous thiamine (vitamin B1) on renal injury in septic shock. Patients admitted with septic shock who have a lactate of at least 2.0mmol/L and do not have pre-existing renal failure requiring dialysis will be eligible for the study. Enrolled patients will be randomized to intravenous thiamine 200mg twice daily for 6 doses or matching placebo. Blood will be drawn at several time points to assess biomarkers of renal injury. Secondary endpoints include need for renal replacement therapy, length of ICU stay, and hospital mortality.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A randomization list will be prepared by an independent statistician using 1:1 randomization in blocks of two and four. This list will be provided to the research pharmacy, and the research pharmacy will be the only unblinded people involved with the study, and will have no patient contact or role in the analysis or other aspects of the study. Thiamine is colorless and odorless, and the 200mg dose is mixed in 5mL of normal saline. Placebo will be 50mL of normal saline and is indistinguishable in appearance from thiamine. Study team, clinical team and patient and family will all be blind to the allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ≥18 years of age
- •Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and provision of an antimicrobial)
- •Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)
- •Serum lactate ≥2mmol/L
- •Creatinine >1.0mg/dL
排除标准
- •Clinical indication for thiamine administration (alcoholism, known or highly suspected deficiency) or treatment with thiamine beyond the amount found in a standard multivitamin within the last 10 days
- •Renal replacement therapy within the past 30 days
- •Comfort measures only or anticipated withdrawal of support within 24 hours
- •Protected populations (pregnant women, prisoners)
- •Known thiamine allergy
研究组 & 干预措施
Thiamine
200mg parenterally administered thiamine hydrochloride given twice daily for a 3 days (6 doses)
干预措施: Thiamine Hydrochloride (Drug)
Placebo
Matching placebo (50ml 0.9%NACL) given twice daily for 3 days (6 administrations)
干预措施: Placebo (Drug)
结局指标
主要结局
Kidney Injury Biomarker
时间窗: Enrollment to 72-hours
Change in creatinine over time
次要结局
- Number of Participants Receiving Renal Replacement Therapy(From date of enrollment until discharge from the intensive care unit (ICU) or date of death, whichever comes first, up to 60 days after enrollment)
- Change in Lactate Level(From time of enrollment until 72 hours after enrollment)
- Number of Participants With Delirium on Day 3(Day 3 after enrollment)
- In-hospital Mortality(From date of enrollment until discharge from the hospital or date of death, whichever comes first, up to 60 days after enrollment)
- Novel Biomarkers of Renal Injury(24 hours after enrollment)
- ICU Free Days(From date of enrollment until 28 days after enrollment)
- Number of Participants Experiences Acute Renal Failure(From date of enrollment until day of discharge from the index ICU admission or date of death, whichever comes first up until 60 days post-enrollment)
- Change in the Sequential Organ Failure Assessment Score(Time of enrollment until 72 hours after enrollment)
研究者
Michael Donnino
Associate Professor of Emergency Medicine
Beth Israel Deaconess Medical Center