Thiamine Supplementation in Patients With Septic Shock: A Randomized, Double Blind, Placebo Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time to Reversal of Shock
研究概览
简要总结
To determine if intravenous thiamine would decrease the time to reversal of shock in patients with septic shock.
详细描述
Patients will be randomized to thiamine supplementation or placebo in a 1:1 ratio. Randomization will be done by the hospital pharmacy department whom will be the only unblinded participants. Patients will receive 200mg thiamine in 50mL of 5% dextrose or matching placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit. The drug will be mixed by the pharmacy. Administration will be done in the patients room in the intensive care unit by the patient's assigned nurse. Blood will be collected on admission to the hospital in order to determine baseline lactate level and study eligibility. The measurement of lactate is standard of care in patients with sepsis. Thiamine level will be collected upon enrollment into the study. The ICU nurse or emergency room nurse taking care of the patient at the time of enrollment will draw the blood sample. Standard procedure for measuring thiamine levels will be maintained including protecting the blood sample from light and keeping it on ice while it is delivered to the lab. Serum lactate will be measured daily for 7 days or until discharge from the intensive care unit. The serial measurement of serum lactate is considered standard of care in patients with sepsis.
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)
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
- •Sepsis (defined as presence of two or more SIRS criteria with documented or suspected infection)
- •SIRS: Systemic Inflammatory Response Syndrome (SIRS) is the occurrence of at least two of the following criteria: temperature >38.0ºC or <36.0ºC, heart rate >90 beats/minute, respiratory rate >20 breaths/minute, white blood cell count >12,000 or <
- •Lactate >3mmol/L at the time of consent and randomization
- •Hypotension (systolic blood pressure <90mmHg) after a >2L fluid bolus
- •Vasopressor dependence (defined as the continuous infusion of norepinephrine, dopamine, phenylephrine, vasopressin or epinephrine.)
排除标准
- •Known cirrhosis or chronic liver disease
- •Current thiamine supplementation
- •Clinical indication for thiamine (e.g. Alcohol abuse)
- •Comfort measures only designation
- •Inability to provide consent
- •Other causes for lactate elevation (seizure, use of medications that can cause lactic acidosis such as metformin, linezolid and anti-retrovirals, carbon monoxide, known or suspected bowel or limb ischemia, cardiac arrest prior to enrollment)
研究组 & 干预措施
Placebo Group
Patients will receive placebo (50mL 5% dextrose) once daily for 7 days or until discharge from the intensive care unit.
干预措施: Placebos (Drug)
Thiamine Supplementation Group
Patients will receive 200mg thiamine in 50mL of 5% dextrose once daily for 7 days or until discharge from the intensive care unit.
干预措施: Thiamine (Drug)
结局指标
主要结局
Time to Reversal of Shock
时间窗: 7 days
Number of hours that the patient required vasopressors
Time to Normalization of Lactic Acidosis
时间窗: 7 days
次要结局
- ICU Length of Stay(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- ICU Mortality(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
研究者
Jinesh Mehta
Staff Physician
The Cleveland Clinic