Dexmedetomidine and Vasopressin (DEX-PRESSIN) for Reducing In-hospital Mortality in Septic Shock Patients: A Protocol for Randomized Controlled Trial (DecatSepsis-2)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 260
- 主要终点
- in-hospital mortality
研究概览
简要总结
Rudiger and Singer suggested strategies for refining adrenergic stress (decatecholaminization). They proposed the use of dexmedetomidine and vasopressin to reduce the catecholamine load during sepsis. The investigators will use vasopressin as the primary vasopressor and a heart rate-calibrated dexmedetomidine infusion in septic shock patients.
The investigators of the current study will use DEXPRESSIN in septic shock patients to investigate the effects of decatecholaminization on in-hospital mortality.
详细描述
The investigator will include 260 patients with septic shock. The study will compare the use of vasopressin as the first-line vasopressor in septic shock in addition to the dexmedetomidine infusion as in the DecatSepsis trial versus the standard of care. The standard of care is guided by the Surviving Sepsis campaign in 2021.
The main outcomes of the study are in-hospital mortality, norepinephrine equivalent dose, ICU scores, and inflammatory markers.
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor will be nurses - not invovled in the study - will be unware about the study drug.
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 patients who develop septic shock in whom a vasopressor is initiated to maintain a mean arterial blood pressure (MAP) of ≥65 mmHg in the presence of sepsis (≥2 SIRS criteria plus suspicion or confirmation of infection).
排除标准
- •Patient refusal or inability to obtain consent
- •Failure of hemodynamic stabilization or hemoglobin <7 g/dL at the time of inclusion
- •Severe cardiac dysfunction [i.e., ejection fraction (EF) <30%]
- •History of heart block or patient on pacemaker
- •Severe valvular heart disease
- •Chronic liver disease (Child-Pugh classification C)
- •Pregnancy
- •Patients with traumatic brain injury
研究组 & 干预措施
DEX-PRESSIN
This group will receive vasopressin as the first-line vasopressor. DEX will be started after hemodynamic stabilization if the heart rate is >90 beats per minute (bpm). NE infusion will be the second-line vasoactive drug.
干预措施: DEX-PRESSIN (Drug)
Standard-of-care group
This group will receive conventional treatment according to the Surviving Sepsis Campaign 2021 guidelines. This group will receive vasopressin as the second line after NE and will not receive dexmedetomidine.
干预措施: Standard of Care (Drug)
结局指标
主要结局
in-hospital mortality
时间窗: throughout the hospitalization period on average 90 days.
All-cause inhospital mortality as a binary outcome
次要结局
- Duration of vasopressor infusion in survivors(through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days)
- Initiation of invasive mechanical ventilation (IMV)(through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days)
- Hospital length of stay(during hospitlaization period on average 90 days)
- survival analysis(through out the hospitalization period or 28 days after inclusion if discharged from hosptia; before 28 days)
- Norepinephrine Equivalent Dose (NED)(over the first three days after enrolment or death)
- Duration of IMV(through out the hospitalization period or 28 days after inclusion if discharged from hosptial before 28 days)
- Early acute kidney injury (AKI)(within 48 hours)
- Late acute kidney injury (AKI)(between 48 hours and 7 days)
- Acute Physiology and Chronic Health Evaluation (APACHE-II)(on the 3rd day after enrollment)
- Simplified Acute Physiology Score (SAPS) II score(on the 3rd day after enrollment)
- ICU length of stay(during hospitalization period on average 90 days)