Characterization of the Efficacy of Furosemide Depending on Albumin Function - a Prospective Monocentric Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of the levels of the patient-specific unbound furosemide fraction in correlation to the ABiC
研究概览
简要总结
During this prospective, uncontrolled and non-interventional observational study, the influence of albumin function on the efficacy of furosemide will be investigated. The aim of the study is to provide information on the efficacy of furosemide depending on albumin function.
详细描述
In patients with intravenous furosemide administration, an additional 15 ml of blood is taken for the analysis of specific parameters as part of the blood sampling necessary for the treatment of the patient.
The effect of furosemide is assessed on the basis of the patient's urine excretion. For this purpose, fluid intake and excretion are balanced over 6 hours. The blood sample is taken at the beginning of the balancing period.
In addition, the albumin concentration, ABiC, as well as the total and free concentration of furosemide in the collected urine are determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Informed consent
- •Attending intensive care physician intends to prescribe IV furosemide to increase urine output
- •Arterial (central venous if applicable) and urinary catheter in situ
排除标准
- •Attending intensive care physician intends to prescribe further doses of diuretic medication (including furosemide infusion) within the 6 hours required for fluid collection
- •Patients who received intravenous or oral diuretics (including mannitol) in the 6 hours prior to study enrolment
- •Patients who have received other medications (e.g. fludrocortisone) known to affect renal sodium or water excretion in the 24 hours prior to study entry
- •Patients with uncontrolled hyperglycaemia (plasma glucose >10mmol/L).
- •Patients who were receiving renal replacement therapy prior to the start of the study
- •Patients with obstructive uropathy, macroscopic haematuria or intra-abdominal hypertension (>20mmHg)
- •Age < 18 years
结局指标
主要结局
Change of the levels of the patient-specific unbound furosemide fraction in correlation to the ABiC
时间窗: 5 minutes post-dose
Assessment of the patient-specific unbound furosemide fraction 5 minutes after furosemid administration
Change in the ratio of urine output to fluid input after initiation of furosemide therapy in correlation to the ABiC
时间窗: 6 hours post-dose
Assessment of the ABiC 5 minutes after furosemid administration as well as urine output and fluid input for 6 hours post-dose for every hour
次要结局
- Influence of disease severity on ABiC(12 hours)
- Influence of biochemical parameters on ABiC(12 hours)
研究者
Gerd Klinkmann
Principal Investigator
University of Rostock