Outcomes of Renal Function in Hepatorenal Syndrome (HRS) Determined By Comparison of Target Mean Arterial Pressure (MAP) of 65 - 70 Mmhg Versus ≥ 85 Mmhg
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- serum creatinine
研究概览
简要总结
Comparing renal outcomes based on a Mean Arterail Pressure (MAP) of 65-7085mmhg versus a MAP of greater than or equal to 85mmhg
详细描述
Main hypothesis:
The investigators propose that there will be no difference clinical outcomes as evidenced by a significant difference in urine output or change in creatinine between the MAP target ≥ 85mmhg and the MAP target of 65-70 mmhg.
Primary end point:
To determine if High MAP or Low MAP will provide the most optimal renal function. The primary endpoints will be 96h UOP and change in creatinine levels. UOP will be calculated as cc/24 hours. The investigators will compare the change in urinary output of day 1 versus day 4. Creatinine will be measured daily and the change from initiation to completion of the study will be recorded. The mean values of these will be compared.
Secondary end point:
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission to intensive care unit (ICU)
- •Age >18 years old
- •Able to obtain informed consent obtained from the patient, from the patient's power of attorney, or from the next of kin
- •Must meet all major criteria based on the International Ascites Club definition and diagnostic criteria for Hepatorenal Syndrome:
- •chronic or acute liver disease with advanced hepatic failure and portal hypertension;
- •the serum creatinine is greater than
- •5 mg/dL or 24 hour creatinine clearance of less than 40 ml/min;
- •absence of shock, ongoing bacterial infection, and current or recent treatment with nephrotoxic drugs;
- •absence of gastrointestinal fluid losses (repeated vomiting or intense diarrhea) or renal fluid losses;
- •no sustained improvement in renal function defined as a decrease in serum creatinine to less than 1.5 mg/dL or increase in 24 hour creatinine clearance to 40 ml/min or more following diuretic withdrawal and expansion of plasma volume with 1.5 L of isotonic saline;
- •proteinuria less than 500 mg/dL;
- •no ultrasonic evidence of obstructive uropathy or parenchymal renal disease.
- •In addition, patients must meet the definition of HRS type I or HRS type I
- •HRS I defined by a rapid deterioration in kidney function with the serum creatinine increasing by more than 100% from baseline to greater than 2.5mg/dl within a two week period.
- •HRS II defined as: patients with refractory ascites with either a steady but moderate degree of functional renal failure (≥ 1.5mg/dl) or deterioration in kidney function that does not fulfill the criteria for HRS type I
排除标准
- •pre-existing continuous renal replacement therapy cannot or those initiated on dialysis during their hospital stay.
- •artificial liver support therapies
- •ongoing gastrointestinal bleeding
- •active surgical issues
- •pre-existing TIPS or TIPS placed during hospital stay
- •long standing hypertension
- •improvement in renal function after central blood volume expansion contraindications to norepinephrine (active myocardial event, ventricular arrhythmia, obstructive physiology, limb ischemia)
- •Treating physicians refusing to enroll patient
研究组 & 干预措施
MAP 65-70
Goal MAP of 65-70
干预措施: Norepinephrine (Levophed) (Drug)
MAP greater than or equal to 85
MAP greater than or equal to 85
干预措施: Norepinephrine (Levophed) (Drug)
结局指标
主要结局
serum creatinine
时间窗: 2 years
Urine output
时间窗: 2 years
To determine if High MAP or Low MAP will provide the most optimal renal function. The primary endpoints will be 96h UOP and change in creatinine levels. UOP will be calculated as cc/24 hours. We will compare the change in urinary output of day 1 versus day 4. Creatinine will be measured daily and the change from initiation to completion of the study will be recorded. The mean values of these will be compared.
次要结局
- Cardiac events(2 years)
- ischemic events(2 years)
研究者
Mohamed Saad
Associate professor of medicine
University of Louisville