Effect of Albumin Administration on Vasopressor Duration in Resolving Septic Shock
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Time to Cessation of Vasopressor Therapy
研究概览
简要总结
The role of albumin in sepsis has been controversial for decades. Although hypoalbuminemia has been associated with worse outcomes in sepsis, definitive evidence does not exist that replacing albumin in these patients improves outcomes. However, subgroup analyses from large clinical trials indicate that albumin may reduce mortality in septic shock, and in particular, may reduce the time a patient requires vasopressor support. Given this background, we are conducting this study to evaluate the role of albumin replacement in the patient with resolving septic shock to determine if albumin administration reduces the time a patient requires vasopressor support, reduces the time required for central line, and ultimately whether any potential benefit in terms of reduction of vasopressor support is associated with ICU length of stay and other outcomes. The approach is unique from larger trials of albumin in that it is a septic shock study geared at a particular phenotype of the patient in septic shock and evaluating a specific intervention at a specific time point in the course of septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •18 years of age or older who meet the clinical criteria for septic shock
- •a. Presence of two or more of the following: i. A core temp ≥38C or ≤36C; ii. A heart rate ≥90 beats/min; iii. A respiratory rate ≥ 20 breaths/min or PaCO2 ≤32mmHg or use of mechanical ventilation for an acute process; iv. A white blood cell count ≥12000/ml or ≤4000/ml or immature neutrophils > 10%.
- •b. Presence of defined (or suspected) site of infection as show by at least one of the following criteria: i. An organism grown in blood or sterile site; ii. An abscess or portion of infected tissue; iii. Suspected infection despite culture growth by the attending physician. c. Infusion of vasopressors is required to maintain blood pressure
- •Vasopressor requirements
- •a. Patients can be considered for study inclusion when his/her vasopressor requirements are as follows: i. Norepinephrine 0.04-0.25 mcg/kg/min (plus or minus vasopressin) OR phenylephrine 0.2-2 mcg/kg/min (plus or minus vasopressin) AND ii. Last measured lactate value was < 4 mmol/L AND iii. The patient is on stable or decreasing doses of vasopressors for 8 hours or more. This 8 hour measurement will start at the maximum amount of vasopressor support within the range defined in i. above.
- •Serum albumin level <2.5g/dl. The level must be drawn within the last 24 hours of Time=0.
排除标准
- •Patients <18 years old
- •Albumin administration 24 hours prior to the time of enrollment (Time=0)
- •Terminal state
- •Known adverse reaction to albumin administration
- •Pathological conditions in which albumin administration is clinically indicated (hepatic cirrhosis with ascites, hepatorenal syndrome, intestinal malabsorption syndrome, nephrotic syndrome, burns)
- •Patients with acute liver failure or cirrhosis
- •Patients on continuous renal replacement therapy
- •Patients who are morbidly obese ≥40kg/m2
- •Religious objection to the administration of human blood products.
研究组 & 干预措施
25% Albumin
25% albumin 75 grams IV over 1 hour once.
干预措施: 25% Albumin (Drug)
Placebo
0.9% normal saline 200mL IV over 1 hour once.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Cessation of Vasopressor Therapy
时间窗: Until ICU Discharge (up to 28 days after study drug administration)
Time from study drug administration to when the patient no longer requires vasopressor support
次要结局
- Time to Central Line Discontinuation(Until ICU Discharge (up to 28 days after study drug administration))
- Time on Mechanical Ventilation(Until ICU Discharge (up to 28 days after study drug administration))
- ICU Length of Stay(Until ICU Discharge (up to 28 days after study drug administration))
- Heart Rate(Measured hourly until 24 hours following study drug administration)
- ICU Mortality(Until ICU Discharge (up to 28 days after study drug administration))
- Central venous pressure(Measured hourly until 24 hours following study drug administration)
- Mean arterial pressure(Measured hourly until 24 hours following study drug administration)
- Serum creatinine(Measured the day following study drug administration)
- Urine output(Measured for 24 hours following study drug administration)
研究者
Alexander Flannery, 859-323-4011
Sponsor/PI
University of Kentucky