Amino Acid Effluent Loss During Continuous Renal Replacement Therapy: an Explorative Non-interventional Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Amino acid effluent loss
研究概览
简要总结
The goal of this observational study is to learn about amino acid loss during continuous renal replacement therapy and plasma amino acid levels in intensive care patients. The main questions it aims to answer are:
What amount of amino acids is lost over the duration of continuous renal replacement therapy? How do amino acid plasma concentrations change over time in patients with and without continuous renal replacement therapy?
Amino acid concentrations will be measured in the effluent and in the plasma of patients receiving continuous renal replacement therapy as part of their regular medical care. In addition, plasma concentrations of amino acids will be studied in patients without renal replacement therapy.
详细描述
In order to quantify the amount of amino acids lost via the continuous renal replacement (CRRT) machine, it is warranted to measure amino acid concentrations in the blood and effluent over the entire treatment period.
To this end, 20 intensive care patients will be examined throughout the entire duration of CRRT as part of this exploratory non-interventional study. Additionally, 10 intensive care patients without renal replacement therapy will be enrolled. In the CRRT-group amino acid loss through the effluent will be measured at different time points. Amino acid plasma concentrations will be determined in both groups. Amino acid urine concentration, nitrogen balance, as well as blood urea nitrogen, creatinine and albumin in the plasma will be measured as secondary outcome parameters. Additionally, observations regarding nutritional status and mobility (indirect calorimetry, bioimpedance analysis, ultrasound muscle and adipose tissue thickness, strength and mobility scoring) will be analyzed as exploratory secondary outcomes.
Duration of CRRT, length of intensive care and hospital stay as well as mortality will be monitored.
High-performance liquid chromatography fluorescence as well as liquid chromatography-mass spectrometry will be performed to measure amino acid concentrations in plasma, effluent and urine.
To answer the primary research question, change in amino acid plasma concentrations and effluent loss between treatment start and day 4 of continuous renal replacement therapy will be analysed using a two-sided Wilcoxon signed rank test.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Amino acid effluent loss
时间窗: CRRT start, day 4 of continuous renal replacement therapy
Change of effluent loss of amino acids from start of continuous renal replacement therapy to day 4
Amino acid plasma concentration CRRT group
时间窗: day 0, day 4 of continuous renal replacement therapy
Change of plasma concentration of amino acids from start of continuous renal replacement therapy to day 4
Amino acid plasma concentration non-CRRT group
时间窗: preoperative day/enrollment to postoperative day 4
Change of plasma concentration of amino acids from the preoperative day to postoperative day 4 or to the last measurement at the intensive care unit, whichever is earlier
次要结局
- Time course of effluent loss of amino acids over all measured time points(duration of continuous renal replacement therapy, maximum 30 days)
- Time course of plasma concentration of amino acids over all measured time points(preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Urine concentration of amino acids over treatment period(preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Nitrogen balance(duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Blood urea nitrogen(preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Creatinine(preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Albumin(preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Total protein(preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Vitamins(duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Trace elements(duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Indirect Calorimetry(duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Bioimpedance analysis(preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Ultrasound Muscle and Adipose Tissue Thickness(preoperative if recruited preoperatively, duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Muscle Strength(duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Mobility(duration of continuous renal replacement therapy (CRRT group) or length of ICU stay (non CRRT-group), maximum 30 days)
- Duration of Continuous Renal Replacement Therapy(duration of Continuous Renal Replacement Therapy (CRRT group), through study completion on average 10 days)
- Length of stay(length of ICU and hospital stay, through study completion maximum 1 year)
- Mortality(length of ICU and hospital stay, through study completion maximum 1 year)
研究者
Arabella Fischer, MD
Principal investigator
Medical University of Vienna