A Randomized Controlled Pilot Trial of Phenylephrine Versus Norepinephrine for Septic Shock in Critically Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Maximum Heart Rate
研究概览
简要总结
Septic shock is a condition that is marked by severe infection causing hypotension requiring vasopressors to maintain adequate perfusion to vital organs. The Surviving Sepsis campaign, an international organization formed for the purpose of guiding the management of sepsis and septic shock, currently recommends norepinephrine as the first-choice vasopressor for septic shock. Phenylephrine, a vasopressor FDA-approved for use in septic shock, is recommended as an alternative vasopressor when septic shock is complicated by tachyarrhythmia to mitigate cardiac complications. This recommendation is based solely on experience with no scientific evidence to support this recommendation.
The investigators will conduct an open-label randomized controlled trial (RCT) directly comparing phenylephrine and norepinephrine, two FDA-approved vasopressors that are both used in clinical practice for the management of septic shock. The investigators will perform this study with a population of patients that have septic shock to complete the following aims:
Aim 1: Determine the incidence of tachyarrhythmias.
Aim 2: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a lower heart rate.
Aim 3: Determine which vasopressor, phenylephrine or norepinephrine, is associated with a higher incidence of new tachyarrhythmias.
Aim 4: Determine which vasopressor, phenylephrine or norepinephrine, is associated with less time in tachyarrhythmia.
Aim 5: Determine which vasopressor, phenylephrine or norepinephrine, is associated with fewer complications, including cardiac complications.
The investigators hypothesize that in this setting, phenylephrine will improve the management of septic shock when used as a "first choice" vasopressor by:
- Decreasing the mean heart rate
- Decreasing the incidence of new tachyarrhythmias
- Decreasing the amount of time spent in tachyarrhythmia for patients who develop new onset and recurrent tachyarrhythmias
- Decreasing the number of cardiac complications
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
- None
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
- •Adults 18 years of age or greater
- •Intention to treat with vasopressor for diagnosis of septic shock
- •Exclusion criteria not met
排除标准
- •Emergent indication for surgery
- •Patient possesses a terminal condition for which patient or medical decision maker has decided to de-escalate medical care (patients with Do Not Resuscitate order but for whom standard care is continued will not be excluded)
- •Known allergy to phenylephrine or norepinephrine
- •Treated with vasopressor >12 hours for current episode of shock
- •Preference of specific vasopressor agent by patient's provider
- •Pregnancy
研究组 & 干预措施
Phenylephrine
Phenylephrine will be administered as the primary vasopressor for the treatment of septic shock
干预措施: Phenylephrine (Drug)
Norepinephrine
Norepinephrine will be administered as the primary vasopressor for the treatment of septic shock
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Maximum Heart Rate
时间窗: Up to 28 days
次要结局
- Cause of Death(Up to 28 days)
- CK-MB(Up to 28 days)
- Hospital Days Not in ICU(Up to 28 days)
- Total Time in Arrhythmia(Up to 28 days)
- Number of Days Mechanical Ventilation Needed(Up to 28 days)
- Number of Participants Developing Peripheral Limb Ischemia(Up to 28 days)
- Number of Patients With ST-segment Abnormalities on ECG(Up to 28 days)
- Number of Participants With Arrhythmia Events(Up to 28 days)
- Length of Hospital Stay(Up to 28 days)
- Location of Death(Up to 28 days)
- Number of Times an Anti-arrhythmic Agent is Used(Up to 28 days)
- Use of Corticosteroid(Up to 28 days)
- Number of Uses of Rate-controlling Agent(Up to 28 days)
- Number of Direct Current (DC) Cardioversion Events(Up to 28 days)
- Number of Days Without Mechanical Ventilation(Up to 28 days)
- Number of Days Hemodialysis Needed(Up to 28 days)
- Mean Sequential Organ Failure Assessment (SOFA) Score(Up to 28 days)
- Number of Participants With Cardiac Arrest Events(Up to 28 days)
- Number of Days Without Vasopressor Use(Up to 28 days)
- Days Spent Out of the Hospital(Up to 28 days)
- Number of Participants Receiving Non-study Vasopressors(Up to 28 days)
- Amount of Time Non-study Vasopressors Used(Up to 28 days)
- Days Without Dialysis(Up to 28 days)
- Readmission to ICU(Up to 28 days)
- Number of Participants Rehospitalized After Discharge(Up to 28 days)
- Length of ICU Stay(Up to 28 days)
- 28-day Mortality(Up to 28 days)
- Creatinine Kinase (CK)(Up to 28 days)
- Mean Troponin-I(Up to 28 days)